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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71134

35 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 06, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

35 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 35

MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1759-2015
Recall number
Z-1759-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
125 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728131; Serial #s: EP16E130006, EP16E130007, EP16E130009, EP16E130010, EP16E130012, EP16E130013, EP16E130014, EP16E130015, EP16E130016, EP16E130017, EP16E130020, EP16E130021, EP16E130022, EP16E130023, EP16E130025, EP16E130026, EP16E130027, EP16E130029, EP16E130030, EP16E130031, EP16E130033, EP16E130034, EP16E130035, EP16E130036, EP16E130037, EP16E130040, EP16E130041, EP16E130042, EP16E130043, EP16E130044, EP16E130045, EP16E130046, EP16E130047, EP16E130048, EP16E130049, EP16E130050, EP16E130051, EP16E130052, EP16E130053, EP16E130055, EP16E130056, EP16E130057, EP16E130058, EP16E130062, EP16E130063, EP16E130064, EP16E130065, EP16E130066, EP16E130067, EP16E130068, EP16E130069, EP16E130070, EP16E130071, EP16E130072, EP16E130073, EP16E130074, EP16E130075, EP16E130077, EP16E130078, EP16E130079, EP16E130080, EP16E130082, EP16E130083, EP16E130086, EP16E130087, EP16E130088, EP16E130089, EP16E130092, EP16E130093, EP16E130094, EP16E130095, EP16E130097, EP16E130098, EP16E130099, EP16E130100, EP16E130102, EP16E130103, EP16E130105, EP16E130106, EP16E130107, EP16E130109, EP16E130110, EP16E140001, EP16E140002, EP16E140003, EP16E140007, EP16E140008, EP16E140009, EP16E140010, EP16E140011, EP16E140012, EP16E140014, EP16E140015, EP16E140016, EP16E140017, EP16E140018, EP16E140019, EP16E140021, EP16E140022, EP16E140024, EP16E140025, EP16E140027, EP16E140029, EP16E140035, EP16E140039, EP16E140041, EP16E140042, EP16E140050, EP16E140057, EP16E140059, EP16E140075, EP16EB110006, EP16EB120006, EP16EB120007, EP16EB120008, EP16EB120009, EP16EB130001, EP16EB130002, EP16EB130003, P16E090027 & P16EM09002

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 2 of 35

MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1760-2015
Recall number
Z-1760-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728132; Serial #s: EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008 & EP16ER110009.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 3 of 35

Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1761-2015
Recall number
Z-1761-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
788 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728231; Serial #s: 7521, 7546, 9038, 9043, 9044, 9047, 9050, 9072, 9106, 9120, 9152, 9168, 9234, 9250, 9516, 9526, 9535, 9551, 9552, 9564, 9604, 9627, 9641, 9654, 9655, 9663, 9664, 9690, 9701, 9763, 9782, 9870, 9915, 9982, 9996, 10066, 10067, 10188, 10201, 10213, 10216, 10218, 10221, 10222, 10223, 10225, 10226, 10227, 10229, 10235, 10237, 10242, 10245, 10248, 10250, 10251, 10253, 10254, 10256, 10257, 10258, 10259, 10261, 10263, 10265, 10266, 10267, 10269, 10270, 10271, 10274, 10275, 10276, 10277, 10278, 10279, 10280, 10281, 10282, 10283, 10284, 10285, 10286, 10287, 10288, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10316, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10327, 10330, 10331, 10332, 10333, 10334, 10335, 10336, 10337, 10338, 10339, 10341, 10342, 10343, 10344, 10345, 10346, 10347, 10348, 10349, 10350, 10351, 10352, 10353, 10354, 10355, 10357, 10358, 10359, 10360, 10361, 10362, 10363, 10365, 10366, 10367, 10368, 10369, 10370, 10371, 10372, 10373, 10374, 10375, 10376, 10378, 10379, 10380, 10381, 10383, 10384, 10385, 10386, 10388, 10389, 10390, 10391, 10392, 10393, 10394, 10395, 10396, 10398, 10399, 10400, 10401, 10402, 10403, 10404, 10405, 10406, 10407, 10408, 10409, 10410, 10411, 10412, 10413, 10414, 10415, 10416, 10417, 10418, 10419, 10420, 10421, 10422, 10424, 10425, 10426, 10427, 10428, 10429, 10430, 10431, 10432, 10434, 10435, 10436, 10437, 10438, 10439, 10440, 10441, 10442, 10443, 10444, 10445, 10446, 10447, 10448, 10449, 10450, 10451, 10452, 10453, 10454, 10455, 10456, 10457, 10458, 10459, 10460, 10461, 10462, 10463, 10464, 10465, 10466, 10467, 10468, 10469, 10470, 10471, 10472, 10473, 10474, 10475, 10476, 10477, 10478, 10479, 10480, 10481, 10482, 10483, 10484, 10485, 10486, 10487, 10488, 10489, 10490, 10491, 10492, 10495, 10496, 10497, 10498, 10499, 10500, 10502, 10503, 10504, 10505, 10507, 10508, 10510, 10511, 10512, 10513, 10514, 10515, 10516, 10517, 10518, 10519, 10520, 10521, 10522, 10523, 10525, 10526, 10527, 10528, 10530, 10531, 10532, 10533, 10534, 10535, 10536, 10537, 10538, 10539, 10540, 10541, 10542, 10543, 10545, 10546, 10547, 10548, 10549, 10550, 10551, 10552, 10553, 10554, 10555, 10556, 10557, 10558, 10559, 10560, 10561, 10562, 10563, 10564, 10565, 10566, 10567, 10568, 10569, 10570, 10571, 10572, 10573, 10574, 10575, 10576, 10577, 10578, 10579, 10581, 10583, 10584, 10585, 10586, 10587, 10588, 10589, 10590, 10591, 10592, 10593, 10594, 10595, 10596, 10597, 10598, 10599, 10600, 10601, 10602, 10603, 10604, 10605, 10606, 10607, 10608, 10609, 10610, 10611, 10612, 10613, 10614, 10615, 10616, 10617, 10618, 10619, 10621, 10622, 10623, 10624, 10625, 10626, 10627, 10628, 10629, 10630, 10631, 10632, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 10640, 10642, 10643, 10644, 10645, 10646, 10648, 10649, 10650, 10651, 10652, 10653, 10654, 10655, 10656, 10657, 10658, 10659, 10660, 10661, 10662, 10663, 10664, 10665, 10666, 10667, 10668, 10669, 10670, 10671, 10673, 10674, 10675, 10676, 10677, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10685, 10686, 10687, 10688, 10689, 10690, 10691, 10692, 10693, 10694, 10695, 10697, 10698, 10699, 10700, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10710, 10712, 10713, 10714, 10715, 10716, 10717, 10718, 10720, 10721, 10722, 10723, 10724, 10725, 10726, 10727, 10728, 10729, 10730, 10731, 10732, 10733, 10734, 10735, 10736, 10737, 10738, 10739, 10740, 10741, 10742, 10744, 10745, 10747, 10748, 10749, 10750, 10751, 10752, 10753, 10754, 10755, 10756, 10757, 10758, 10759, 10760, 10761, 10762, 10765, 10767, 10768, 10769, 10770, 10771, 10772, 10773, 10774, 10775, 10776, 10777, 10778, 10779, 10780, 10781, 10782, 10783, 10784, 10785, 10786, 10789, 10790, 10792, 10793, 10794, 10795, 10796, 10797, 10798, 10799, 10800, 10801, 10802, 10803, 10804, 10805, 10806, 10807, 29002, 29014, 29016, 29018, 29027, 29038, 29051, 90128, 90144, 90156, 95041, 95055, 95058, 95107, 95345, 95350, 95441, 95567, 95611, 95700, 95702, 95703, 95704, 95705, 95706, 95707, 95709, 95710, 95711, 95712, 95713, 95714, 95715, 95716, 95718, 95719, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95743, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95764, 95765, 95767, 95768, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95782, 95783, 95784, 95785, 95786, 95787, 95788, 95789, 95790, 95791, 95792, 95793, 95794, 95795, 95796, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95814, 95815, 95816, 95817, 95818, 95819, 95820, 95821, 95822, 95823, 95824, 95825, 95826, 95827, 95828, 95829, 95830, 95831, 95833, 95834, 95835, 95836, 95837, 95842, 95843, 95845, 95848, 95849, 95850, 95851, 95852, 95853, 95854, 95855, 95856, 95857, 95858, 95859, 95860, 95861, 95862, 95864, 95865, 95867, 95868, 95869, 95870, 95871, 95872, 95873, 95874, 95875, 95876, 95877, 95878, 95879, 95880, 95881, 95884, 95885, 95886, 95887, 95888, 95889, 95890, 95891, 95892, 95894, 95895, 95896, 95897, 95898, 95899, 95900, 95901, 95902, 95903, 95904, 95905, 95906, 95907, 95909, 95910, 95911, 95912, 95913, 95914, 95915, 95916, 95917, 95918, 95919, 95922, 95925, 95926, 95928, 100062, 100089, 100368, 100370 & 100522.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 4 of 35

Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1762-2015
Recall number
Z-1762-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728235; Serial #s: 9266, 9267, 9268, 9269, 9271, 9272, 9273, 9275, 9276, 9277, 9278, 9280, 9281, 9282, 9284, 9285 & 9286.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 5 of 35

Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1763-2015
Recall number
Z-1763-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
376 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728243; Serial #s: 6131, 7221, 7246, 7421, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7487, 7488, 7489, 7491, 7492, 7493, 7494, 7497, 7498, 7499, 7500, 7502, 7503, 7504, 7505, 7506, 7507, 7509, 7511, 7512, 7513, 7515, 7516, 7517, 7518, 7519, 7520, 7521, 7522, 7523, 7524, 7526, 7527, 7528, 7530, 7531, 7532, 7534, 7535, 7537, 7539, 7540, 7541, 7542, 7545, 7547, 7548, 7549, 7550, 7551, 7552, 7553, 7554, 7555, 7556, 7558, 7559, 7560, 7561, 7562, 7563, 7564, 7565, 7566, 7567, 7568, 7569, 7573, 7574, 7577, 7578, 7579, 7580, 7581, 7582, 7584, 7585, 7588, 7589, 7590, 7591, 7592, 7593, 7596, 7597, 7598, 7599, 7601, 7602, 7603, 7605, 7606, 7608, 7609, 7611, 7612, 7613, 7615, 7616, 7617, 7618, 7620, 7622, 7623, 7624, 7626, 7627, 7628, 7629, 7630, 7634, 7635, 7637, 7638, 7639, 7640, 7641, 7642, 7643, 7644, 7645, 7646, 7647, 7648, 7649, 7650, 7652, 7655, 7656, 7657, 7658, 7659, 7661, 7662, 7665, 7666, 7667, 7671, 7672, 7674, 7675, 7677, 7678, 7679, 7680, 7681, 7684, 7685, 7687, 7689, 7690, 7691, 7693, 7695, 7696, 7698, 7699, 7700, 7701, 7702, 7703, 7704, 7705, 7706, 7707, 7709, 7715, 7716, 7718, 7720, 7724, 7725, 7726, 7727, 7728, 7729, 7730, 7731, 7735, 7736, 7737, 7739, 7740, 7741, 7743, 7744, 7745, 7748, 7749, 7750, 7751, 7752, 7753, 7754, 7755, 7757, 7758, 7759, 7761, 7762, 7763, 7765, 7768, 7769, 7770, 7774, 7775, 7776, 7777, 7779, 7782, 7783, 7784, 7785, 7786, 7787, 7788, 7791, 7792, 7793, 7794, 7795, 7796, 7797, 7799, 7800, 7801, 7802, 7803, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7817, 7818, 7820, 7822, 7823, 7824, 7827, 7828, 7829, 7831, 7833, 7834, 7835, 7836, 7837, 7838, 7840, 7841, 7842, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7855, 7856, 7857, 7858, 7860, 7861, 7864, 7865, 7866, 7867, 7868, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7914, 7916, 7918, 7920, 7921, 7923, 7924, 7925, 7927, 7928, 7929, 7931, 7932, 7933, 7935, 7936, 7937, 7938, 7939, 7940, 7941, 7942, 7944, 7945, 7946, 7948, 7949, 7950, 7953, 7954, 7955, 7956, 7963, 7968, 7969, 7970, 7971, 7972, 7973, 7974, 7975, 7976, 7977, 7980, 7984, 7987, 7989, 7990, 7991, 7993, 7994, 7995, 7996, 7997, 7998, 7999, 8002, 8006, 8007 & 18470.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 6 of 35

Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1764-2015
Recall number
Z-1764-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
126 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728244; Serial #s: 7486, 7510, 7514, 7525, 7529, 7533, 7538, 7543, 7544, 7546, 7557, 7570, 7571, 7572, 7575, 7576, 7583, 7586, 7587, 7594, 7595, 7600, 7604, 7607, 7610, 7614, 7619, 7621, 7625, 7631, 7632, 7636, 7651, 7653, 7654, 7660, 7668, 7669, 7670, 7676, 7683, 7686, 7688, 7692, 7694, 7697, 7708, 7710, 7711, 7712, 7713, 7714, 7717, 7719, 7721, 7722, 7723, 7732, 7733, 7734, 7738, 7742, 7746, 7747, 7756, 7760, 7764, 7766, 7767, 7771, 7772, 7773, 7778, 7780, 7781, 7789, 7790, 7798, 7804, 7809, 7813, 7819, 7825, 7826, 7830, 7839, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7943, 7952, 7957, 7958, 7959, 7964, 7967, 7979, 7981, 7986, 7988 & 7992.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 7 of 35

Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1765-2015
Recall number
Z-1765-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
847 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728246; Serial #s: 3007, 3011, 3014, 3047, 3050, 3095, 3117, 3123, 3162, 3164, 3170, 3197, 3247, 3331, 3407, 3433, 3458, 3497, 3578, 3721, 3723, 4015, 4019, 4042, 5013, 5019, 5038, 5040, 5050, 5052, 5090, 5091, 5094, 5097, 5101, 5116, 5133, 5143, 5150, 5155, 5172, 5179, 5180, 5192, 5202, 5252, 5335, 5336, 5342, 5343, 5399, 5416, 5455, 5467, 5601, 5703, 5811, 5869, 5929, 6006, 6012, 6021, 6030, 6037, 6038, 6039, 6043, 6045, 6048, 6051, 6055, 6056, 6064, 6071, 6072, 6074, 6076, 6078, 6079, 6081, 6082, 6083, 6084, 6085, 6087, 6088, 6089, 6090, 6092, 6093, 6094, 6095, 6097, 6100, 6104, 6105, 6107, 6109, 6110, 6111, 6112, 6114, 6116, 6118, 6119, 6120, 6122, 6123, 6124, 6125, 6126, 6127, 6128, 6129, 6130, 6131, 6132, 6133, 6135, 6136, 6137, 6139, 6140, 6141, 6143, 6144, 6145, 6146, 6147, 6148, 6149, 6151, 6153, 6155, 6156, 6157, 6159, 6161, 6162, 6163, 6164, 6165, 6166, 6167, 6168, 6169, 6170, 6171, 6172, 6173, 6174, 6175, 6176, 6177, 6178, 6179, 6180, 6181, 6182, 6183, 6184, 6185, 6186, 6187, 6188, 6189, 6190, 6191, 6192, 6195, 6197, 6198, 6199, 6200, 6201, 6202, 6203, 6204, 6205, 6206, 6207, 6208, 6209, 6210, 6211, 6212, 6213, 6215, 6216, 6217, 6219, 6220, 6221, 6222, 6223, 6224, 6225, 6226, 6227, 6228, 6229, 6230, 6231, 6232, 6233, 6234, 6235, 6237, 6238, 6239, 6240, 6241, 6242, 6243, 6245, 6246, 6247, 6248, 6249, 6250, 6251, 6252, 6253, 6254, 6255, 6256, 6257, 6259, 6260, 6261, 6262, 6264, 6265, 6266, 6267, 6268, 6269, 6270, 6271, 6272, 6273, 6275, 6276, 6279, 6280, 6281, 6282, 6283, 6285, 6287, 6288, 6289, 6290, 6291, 6292, 6293, 6294, 6295, 6296, 6297, 6298, 6299, 6300, 6301, 6302, 6303, 6304, 6306, 6307, 6308, 6309, 6310, 6311, 6312, 6313, 6314, 6315, 6316, 6317, 6319, 6320, 6321, 6322, 6323, 6324, 6325, 6326, 6327, 6328, 6329, 6330, 6331, 6332, 6334, 6335, 6336, 6337, 6338, 6339, 6340, 6341, 6342, 6343, 6344, 6345, 6346, 6347, 6348, 6349, 6350, 6351, 6352, 6353, 6354, 6355, 6356, 6357, 6358, 6359, 6360, 6361, 6362, 6363, 6364, 6366, 6367, 6368, 6369, 6370, 6371, 6373, 6374, 6375, 6376, 6377, 6378, 6379, 6380, 6382, 6383, 6384, 6385, 6386, 6387, 6389, 6392, 6393, 6394, 6395, 6397, 6398, 6399, 6400, 6401, 6402, 6403, 6404, 6405, 6406, 6407, 6408, 6409, 6410, 6411, 6412, 6413, 6414, 6415, 6416, 6418, 6419, 6420, 6421, 6422, 6423, 6424, 6425, 6426, 6427, 6428, 6429, 6430, 6431, 6432, 6433, 6434, 6435, 6436, 6437, 6438, 6439, 6440, 6441, 6442, 6443, 6447, 6448, 6449, 6450, 6451, 6452, 6453, 6454, 6455, 6456, 6457, 6458, 6460, 6461, 6462, 6463, 6464, 6465, 6466, 6467, 6468, 6469, 6470, 6471, 6472, 6473, 6474, 6475, 6476, 6477, 6478, 6479, 6480, 6481, 6482, 6483, 6484, 6485, 6486, 6487, 6488, 6489, 6490, 6491, 6492, 6493, 6497, 6498, 6499, 6500, 6502, 6503, 6504, 6505, 6506, 6507, 6508, 6509, 6510, 6511, 6512, 6513, 6514, 6515, 6516, 6517, 6518, 6519, 6521, 6522, 6523, 6524, 6525, 6526, 6527, 6528, 6529, 6530, 6531, 6532, 6534, 6535, 6536, 6537, 6538, 6539, 6540, 6541, 6542, 6543, 6544, 6545, 6546, 6547, 6548, 6549, 6550, 6551, 6552, 6553, 6554, 6555, 6556, 6557, 6558, 6559, 6560, 6561, 6562, 6563, 6564, 6565, 6566, 6567, 6568, 6569, 6570, 6571, 6572, 6573, 6574, 6575, 6576, 6577, 6580, 6581, 6582, 6583, 6584, 6585, 6586, 6587, 6588, 6589, 6590, 6592, 6593, 6594, 6595, 6596, 6597, 6598, 6599, 6600, 6601, 6602, 6603, 6604, 6605, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6615, 6616, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6638, 6639, 6640, 6641, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6674, 6675, 6676, 6677, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 6696, 6697, 6698, 6699, 6700, 6701, 6702, 6703, 6704, 6705, 6706, 6707, 6708, 6709, 6710, 6711, 6712, 6713, 6714, 6715, 6716, 6717, 6718, 6719, 6720, 6721, 6722, 6723, 6724, 6725, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6733, 6734, 6735, 6736, 6737, 6738, 6740, 6741, 6742, 6743, 6744, 6745, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6755, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6763, 6764, 6765, 6766, 6767, 6768, 6769, 6770, 6771, 6772, 6775, 6777, 6778, 6779, 6782, 6783, 6784, 9744, 30028, 30049, 30051, 30063, 30076, 30100, 30103, 30109, 30110, 30115, 30122, 40018, 40020, 40025, 40032, 50011, 50023, 50028, 50031, 50041, 50049, 50051, 50053, 50143, 50144, 50145, 50146, 50147, 50148, 50149, 50150, 50151, 50152, 50153, 50154, 50156, 50157, 50158, 50159, 50160, 50161, 50162, 50163, 50164, 50165, 50166, 50168, 50170, 50171, 50172, 50175, 50176, 50177, 50178, 50179, 50180, 50181, 50182, 50184, 50185, 50186, 50187, 50188, 50189, 50190, 50191, 50192, 50193, 50194, 50195, 50197, 50198, 50199, 50200, 50201, 50202, 50204, 50223, 50224, 50225, 60007, 60013, 60018, 60020, 260005, 260006, 260007, 260009, 260010, 260011, 260013, 260015, 260016, 260017, 260018, 260019, 260020, 260021, 260022, 260023, 260024, 260025, 260027, 260028, 260029, 260030, 260032, 260035, 260036, 260038, 260039, 260040, 260041, 260042, 260043, 260044, 260045, 260046, 260047, 260048, 260049, 260050, 260051, 260052, 260053, 260056, 260057, 260063, 260064, 260065, 260066, 260067, 260068, 260069, 260070, 260071, 260073, 260074, 260075, 260076, 260077, 260078, 260084 & 260086.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 8 of 35

Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1766-2015
Recall number
Z-1766-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728256; Serial #s: 3683, 3687, 3691, 3692, 3693, 3695, 3696, 3703, 3704, 3705, 3706, 3707, 3708, 3709, 3710, 3711, 3712, 3713, 3714, 3715, 3717, 3718, 3719, 3720 & 3722

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 9 of 35

Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1767-2015
Recall number
Z-1767-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728260; Serial #: 13216

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 10 of 35

Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1768-2015
Recall number
Z-1768-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728306; Serial #s: 85017, 100133, 100135, 100137, 100139, 100141, 100144, 100146, 100149, 100150, 100152, 100153, 100154, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100194, 100195, 100196, 100198, 100199, 100200, 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100208, 100209, 100210, 100211, 100212, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228, 100229, 100230, 100231, 100232, 100233, 100234, 100235, 100236, 100238, 100240, 100242, 100243, 100244, 100245, 100246, 100247, 100248, 100249, 100250, 100251, 100252, 100253, 100254, 100256, 100257, 100258, 100259, 100260, 100261, 100262, 100263, 100264, 100265, 100266, 100267, 100268, 100270, 100271, 100272, 100273, 100274, 100275, 100276, 100277, 100278, 100280, 100281, 100282, 100283, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100293, 100294, 100295, 100296, 100297, 100299, 100300, 100301, 100302, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100310, 100311, 100312, 100313, 100314, 100315, 100316, 100317, 100318, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100328, 100329, 100330, 100331, 100332, 100333, 100334, 100335, 100336, 100337, 100338, 100339, 100340, 100341, 100342, 100343, 100344, 100345, 100346, 100347, 100348, 100349, 100350, 100351, 100352, 100353, 100354, 100355, 100356, 100357, 100358, 100359, 100360, 100361, 100362, 100363, 100364, 100365, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100377, 100378, 100379, 100380, 100382, 100383, 100384, 100385, 100386, 100387, 100388, 100389, 100391, 100393, 100395, 100396, 100397, 100398, 100399, 100400, 100401, 100402, 100403, 100404, 100405, 100406, 100407, 100408, 100409, 100410, 100411, 100412, 100413, 100414, 100415, 100416, 100417, 100418, 100419, 100420, 100423, 100424, 100425, 100426, 100427, 100428, 100429, 100430, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100448, 100449, 100450, 100451, 100452, 100453, 100454, 100455, 100456, 100457, 100458, 100460, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100470, 100473, 100476, 100477, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100487, 100488, 100489, 100490, 100491, 100492, 100493, 100494, 100496, 100497, 100498, 100499, 100500, 100502, 100503, 100504, 100505, 100506, 100507, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100520, 200083 & 200098.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 11 of 35

iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1769-2015
Recall number
Z-1769-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
110 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728311; Serial #s: 200021, 200022, 200023, 200024, 200025, 200026, 200027, 200029, 200030, 200031, 200032, 200033, 200034, 200035, 200036, 200037, 200038, 200039, 200040, 200041, 200042, 200043, 200044, 200045, 200046, 200047, 200048, 200049, 200050, 200051, 200052, 200053, 200054, 200055, 200056, 200057, 200058, 200059, 200060, 200061, 200062, 200063, 200064, 200065, 200067, 200068, 200069, 200070, 200071, 200073, 200074, 200075, 200076, 200077, 200078, 200079, 200080, 200081, 200082, 200084, 200085, 200086, 200087, 200088, 200089, 200090, 200091, 200092, 200093, 200094, 200095, 200096, 200097, 200099, 200100, 200101, 200102, 200103, 200104, 200105, 200106, 200107, 200108, 200109, 200110, 200111, 200112, 200113, 200114, 200115, 200116, 200117, 200119, 200120, 200121, 200123, 200124, 200125, 200126, 200127, 200128, 200129, 200130, 200131, 200133, 200134, 200135, 200136, 200137 & 200138.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 12 of 35

Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1770-2015
Recall number
Z-1770-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728317; Serial #s: 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345022, 345023, 345024, 345028 & 345029.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 13 of 35

Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1771-2015
Recall number
Z-1771-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
215 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728321; Serial #s: 52000, 52001, 52002, 52004, 52006, 52007, 52008, 52009, 52010, 52013, 52015, 52016, 52017, 52018, 52020, 52021, 52022, 52024, 52026, 52033, 52038, 52039, 52046, 52051, 52052, 52057, 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310009, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310081, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 310097, 310099, 310100, 310101, 310102, 310103, 310104, 310105, 310106, 310107, 310108, 310109, 310110, 310111, 310112, 310113, 310114, 310115, 310116, 310117, 310118, 310119, 310120, 310121, 310123, 310124, 310125, 310126, 310128, 310129, 310131, 310132, 310133, 310134, 310135, 310136, 310137, 310138, 310139, 310140, 310141, 310143, 310144, 310145, 310148, 310149, 310151, 310152, 310153, 310154, 310155, 310157, 310158, 310160, 310161, 310162, 310163, 310164, 310165, 310170, 310171, 333001, 333002, 333003, 333005, 333006, 333007, 333008, 333009, 333010, 333011, 333012, 333013, 333014, 333015, 333016, 333017, 333022, 333024, 333025, 333026, 333027, 333030, 333031, 333035, 333037, 333038, 333042, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333057, 333060, 333061, 333066.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 14 of 35

Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1772-2015
Recall number
Z-1772-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
288 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728323; Serial #s: 30153, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32010, 32011, 32013, 32014, 32015, 32016, 32018, 32021, 32023, 32025, 32026, 32029, 32030, 32031, 32032, 32033, 32034, 32035, 32036, 32037, 32038, 32040, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32051, 32052, 32053, 32054, 32057, 32059, 32060, 32062, 32064, 32066, 32068, 32069, 32070, 32072, 32073, 32074, 32077, 32078, 32080, 32083, 32084, 32089, 32091, 32092, 32094, 32095, 32098, 32100, 32101, 32104, 32106, 32107, 32108, 300137, 310067, 320001, 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320073, 320074, 320075, 320076, 320077, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105, 320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 320123, 320124, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320135, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144, 320145, 320146, 320147, 320148, 320150, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336011, 336012, 336013, 336014, 336015, 336016, 336018, 336020, 336021, 336024, 336027, 336028, 336029, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336044, 336046, 336047, 336048, 336050, 336052, 336055, 336056, 336057, 336058, 336059, 336061, 336063, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336074, 336075, 336076, 336080, 336081, 336086, 336087, 336089, 336702, 336703, 336704, 336705, 336706, 336708, 336709, 336710, 336711, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336721, 336707

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 15 of 35

Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1773-2015
Recall number
Z-1773-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
156 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 728326; Serial #s: 30003, 30005, 30006, 30007, 30008, 30009, 30011, 30012, 30013, 30014, 30015, 30018, 30019, 30022, 30028, 300003, 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300024, 300025, 300027, 300028, 300029, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300038, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300046, 300047, 300048, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300085, 300086, 300087, 300088, 300089, 300090, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300116, 300117, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300135, 300136, 300139, 300140, 300142, 300143, 300144, 300145, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 310058 & 30004-1.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 16 of 35

FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1774-2015
Recall number
Z-1774-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882020; Serial #s: 3102, 9908018, 9908021, F01100153, F02020009, F0208354, F02100382, FA05010041, M0005049 & W0002043.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 17 of 35

AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1775-2015
Recall number
Z-1775-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882130; Serial #: 541

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 18 of 35

Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1776-2015
Recall number
Z-1776-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882300; Serial #s: 1041, 1045, 5001, 1072R, 1075R, 1076R & G074.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 19 of 35

Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1777-2015
Recall number
Z-1777-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882320; Serial #s: 1000508, 10000502, 10000504, 10000506, 10000507, 10007040410, B04070065, FA04120026, FA04120029, FA06010213 & FA06110355.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 20 of 35

Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1778-2015
Recall number
Z-1778-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882350; Serial #s: 300072, 3000068, 3000071, 3000073, 3000074, 3000075, 3000076, 3000077, 3000078, 3000079, 3000081, 3000082, 3000083, 3000084, 3000085, 3000086, 3000087, 3000088, 3000089, 3000090, 3000091, 3000092, 3000093, 3000094, 3000095, 3000096, 3000097, 3000098, 3000099, 3000100, 3000101, 3000102, 3000103, 3000104, 3000105 & 3000106.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 21 of 35

Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1779-2015
Recall number
Z-1779-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: Slice882351; Serial #: 3000046

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 22 of 35

Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1780-2015
Recall number
Z-1780-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882380; Serial #s: 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013 & 11014.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 23 of 35

Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1781-2015
Recall number
Z-1781-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882410; Serial #s: 3025, 4003, 4026, 4067, 4076, 4087, 4097, 4102, 4123, 4134, 4201, 4202, 4205, 4206 & 4042003.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 24 of 35

Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1782-2015
Recall number
Z-1782-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882412; Serial #s: 14701, 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710 & 14711.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 25 of 35

TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1783-2015
Recall number
Z-1783-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
31 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882438; Serial #s: 17002, 17003, 17004, 17006, 17007, 17008, 17009, 17011, 17012, 17013, 17014, 17015, 17017, 17018, 17019, 17021, 17022, 17023, 17024, 17025, 17026, 17028, 17030, 17031, 17032, 17033, 17034, 17035, 17036, 17037 & 17038.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 26 of 35

CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1784-2015
Recall number
Z-1784-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
81 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882450; Serial #s: 1106080, 1122002, 2112702, 3101001, 4042003, 4112402, 5032201, 5032902, 5042501, 5060701, 6030802, 7092001, 9042902, 9053001, 9061602, 9070702, 9081002, 9083101, 9083102, 9090301, 9090302, 9091101, 9092201, 9092202, 9101302, 9101901, 9102302, 9102801, 9102802, 9111601, 9111602, 9120902, 10020201, 10062906, 10071301, 10090201, 10090202, 10100501, 10100502, 10100701, 10100702, 10110303, 10110801, 10110802, 10120901, 10120902, 10121001, 10121002, 11021601, 11021602, 11031001, 11031002, 11041201, 11041202, 11051101, 11051102, 11070401, 11070402, 11072102, 11090801, 11090802, 11112301, 11120501, 11120502, 11121201, 11121202, 11121402, 12010601, 12012702, 12020101, 12020102, 12041201, 12052201, 12053001, 12053002, 12071101, 12071102, 12071201, 12071401, 110110804 & 110110806.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 27 of 35

Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1785-2015
Recall number
Z-1785-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model: 882456; Serial #s: 2003, 2004, 2005, 2006, 2007, 2008, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 28 of 35

GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1786-2015
Recall number
Z-1786-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
69 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model: 882456; Serial #s: 2019, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 7018, 7038, 7208, 7210, 7211, 7215, 7216, 7223, 7224, 7226, 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7501, 7503, 7507, 7508, 7511, 7514, 7517, 7518, 7520, 7521, 7523, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7536, 7538, 7540, 7545, 7546, 7554, 7564, 7566, 7568, 7570, 7573, 7581, 7583, 7584, 7586, 7588, 7590, 7591, 7593, 7598, 7599, 7600, 7604, 7605, 7582M & 7596M.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 29 of 35

GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1787-2015
Recall number
Z-1787-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
71 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882471; Serial #s: 7037, 7205, 7206, 7209, 7212, 7213, 7214, 7217, 7218, 7219, 7221, 7227, 7229, 7231, 7234, 7238, 7241, 7245, 7251, 7252, 7253, 7254, 7255, 7256, 7257, 7258, 7504, 7506, 7509, 7510, 7512, 7515, 7516, 7519, 7524, 7525, 7535, 7537, 7539, 7542, 7543, 7544, 7548, 7549, 7550, 7552, 7553, 7555, 7556, 7557, 7558, 7560, 7561, 7562, 7563, 7567, 7569, 7572, 7574, 7577, 7578, 7579, 7585, 7587, 7589, 7592, 7594, 7595, 7602, 7606 & 7575.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 30 of 35

GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1788-2015
Recall number
Z-1788-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882473; Serial #s: 7157, 7237 & 7249.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 31 of 35

GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1789-2015
Recall number
Z-1789-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882476; Serial #s: 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9227, 9228, 9229, 9230, 9232 & 9233.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 32 of 35

BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1790-2015
Recall number
Z-1790-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
108 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882478; Serial #s11000003, 11000004, 11000005, 11000006, 11000008, 11000009, 11000011, 11000012, 11000013, 11000014, 11000015, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000028, 11000029, 11000030, 11000031, 11000033, 11000034, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000045, 11000046, 11000047, 11000048, 11000049, 11000050, 11000051, 11000052, 11000054, 11000055, 11000056, 11000057, 11000058, 11000059, 11000060, 11000061, 11000062, 11000063, 11000064, 11000065, 11000066, 11000067, 11000068, 11000069, 11000070, 11000071, 11000072, 11000073, 11000074, 11000075, 11000076, 11000077, 11000078, 11000080, 11000083, 11000084, 11000085, 11000086, 11000087, 11000088, 11000089, 11000090, 11000091, 11000092, 11000093, 11000094, 11000095, 11000096, 11000097, 11000098, 11000099, 11000100, 11000101, 11000102, 11000103, 11000104, 11000105, 11000106, 11000107, 11000108, 11000109, 11000110, 11000111, 11000112, 11000113, 11000114, 11000115, 11000116, 11000117, 11000118, 11340002, 11340004 & 11340005.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 33 of 35

BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1791-2015
Recall number
Z-1791-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
277 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882480; Serial #s: 466, 4000031, 4000048, 4000077, 4000132, 4000186, 4000251, 4000296, 4000323, 4000336, 4000381, 4000390, 4000403, 4000404, 4000405, 4000406, 4000407, 4000414, 4000415, 4000417, 4000418, 4000419, 4000420, 4000421, 4000423, 4000424, 4000425, 4000426, 4000428, 4000429, 4000430, 4000432, 4000434, 4000435, 4000436, 4000437, 4000438, 4000439, 4000440, 4000441, 4000442, 4000443, 4000444, 4000445, 4000446, 4000447, 4000448, 4000449, 4000450, 4000451, 4000452, 4000453, 4000454, 4000455, 4000456, 4000459, 4000460, 4000461, 4000462, 4000463, 4000464, 4000466, 4000467, 4000468, 4000469, 4000470, 4000473, 4000474, 4000475, 4000476, 4000477, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000486, 4000487, 4000488, 4000489, 4000490, 4000491, 4000492, 4000493, 4000494, 4000495, 4000496, 4000497, 4000498, 4000499, 4000500, 4000501, 4000502, 4000503, 4000504, 4000505, 4000506, 4000507, 4000510, 4000511, 4000513, 4000516, 4000517, 4000518, 4000519, 4000520, 4000521, 4000522, 4000523, 4000524, 4000525, 4000526, 4000527, 4000528, 4000529, 4000530, 4000531, 4000532, 4000533, 4000534, 4000535, 4000536, 4000537, 4000538, 4000539, 4000540, 4000541, 4000542, 4000543, 4000544, 4000546, 4000547, 4000549, 4000550, 4000551, 4000552, 4000553, 4000554, 4000555, 4000556, 4000557, 4000559, 4000560, 4000561, 4000562, 4000563, 4000564, 4000565, 4000566, 4000567, 4000568, 4000569, 4000571, 4000572, 4000573, 4000574, 4000575, 4000576, 4000577, 4000578, 4000579, 4000580, 4000581, 4000582, 4000583, 4000584, 4000585, 4000586, 4000587, 4000588, 4000589, 4000590, 4000591, 4000592, 4000593, 4000594, 4000595, 4000596, 4000597, 4000598, 4000599, 4000600, 4000601, 4000602, 4000603, 4000604, 4000605, 4000606, 4000607, 4000608, 4000609, 4000610, 4000611, 4000612, 4000613, 4000614, 4000615, 4000616, 4000617, 4000619, 4000620, 4000621, 4000622, 4000623, 4000625, 4000626, 4000627, 4000628, 4000629, 4000630, 4000631, 4000632, 4000633, 4000634, 4000635, 4000636, 4000638, 4000639, 4000640, 4000642, 4000643, 4000644, 4000645, 4000646, 4000647, 4000648, 4000649, 4000650, 4000653, 4000654, 4000655, 4000656, 4000657, 4000658, 4000659, 4000660, 4000661, 4000662, 4000663, 4000664, 4000666, 4000667, 4000668, 4000669, 4000670, 4000671, 4000672, 4000673, 4000674, 4000675, 4000676, 4000677, 4000678, 4000679, 4000680, 4000681, 4000683, 4000684, 4000685, 4000686, 4000689, 4000690, 4000692, 4000693, 4000694, 4000695, 4000696, 4000697, 4000698, 4000699, 4340004, 6000102, 40005005, 40007020002, 4000472A & 4000484A.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 34 of 35

BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1792-2015
Recall number
Z-1792-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
337

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 882482; Serial #s: 6000063, 6000065, 6000069, 6000070, 6000071, 6000072, 6000074, 6000077, 6000078, 6000080, 6000083, 6000084, 6000085, 6000089, 6000090, 6000094, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000111, 6000112, 6000113, 6000114, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000122, 6000123, 6000125, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000135, 6000136, 6000138, 6000139, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000163, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000235, 6000236, 6000237, 6000238, 6000239, 6000240, 6000241, 6000242, 6000243, 6000244, 6000245, 6000246, 6000247, 6000249, 6000250, 6000251, 6000252, 6000253, 6000254, 6000255, 6000256, 6000257, 6000258, 6000259, 6000260, 6000262, 6000263, 6000264, 6000265, 6000266, 6000267, 6000268, 6000269, 6000270, 6000271, 6000272, 6000273, 6000274, 6000275, 6000276, 6000277, 6000278, 6000279, 6000280, 6000281, 6000282, 6000283, 6000284, 6000285, 6000286, 6000287, 6000288, 6000290, 6000291, 6000292, 6000293, 6000294, 6000295, 6000296, 6000297, 6000298, 6000299, 6000300, 6000301, 6000302, 6000303, 6000305, 6000306, 6000307, 6000308, 6000309, 6000310, 6000311, 6000312, 6000313, 6000314, 6000315, 6000316, 6000317, 6000318, 6000319, 6000320, 6000321, 6000322, 6000323, 6000324, 6000325, 6000326, 6000327, 6000328, 6000329, 6000330, 6000331, 6000332, 6000333, 6000334, 6000335, 6000336, 6000337, 6000338, 6000339, 6000340, 6000341, 6000342, 6000343, 6000344, 6000345, 6000346, 6000348, 6000349, 6000350, 6000351, 6000352, 6000353, 6000354, 6000355, 6000356, 6000357, 6000358, 6000359, 6000360, 6000361, 6000362, 6000364, 6000365, 6000366, 6000367, 6000368, 6000369, 6000370, 6000371, 6000372, 6000373, 6000374, 6000375, 6000376, 6000377, 6000378, 6000379, 6000380, 6000381, 6000382, 6000383, 6000384, 6000385, 6000386, 6000387, 6000388, 6000389, 6000390, 6000391, 6000392, 6000393, 6000394, 6000395, 6000396, 6000398, 6000399, 6000400, 6000401, 6000402, 6000403, 6000404, 6000405, 6000407, 6000408, 6000409, 6000410, 6000411, 6000412, 6000413, 6000415, 6000416, 6000417, 6000418, 6000419, 6000420, 6000421, 6000422, 6000423, 6000425, 6000426, 6000427, 6340008, 6340009, 6340010, 6340011 & 11000021.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

device · product 35 of 35

Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Z-1793-2015
Recall number
Z-1793-2015
Initiated
March 06, 2015
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Code information

Model #: 889406; Serial #s: 59 & 9806.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.