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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73338

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

Open FDA event record

Event summary

Timeline bucket
February 05, 2016
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

6 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 6

Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Z-1351-2016
Recall number
Z-1351-2016
Initiated
February 05, 2016
Classification
Class II
Status
Terminated
Quantity
285 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Code information

Model No. 728231; S/N: 1, 2, 4001, 9056, 9074, 9099, 9134, 9251, 9515, 9529, 9538, 9549, 9554, 9573, 9574, 9618, 9625, 9638, 9646, 9653, 9656, 9659, 9667, 9670, 9686, 9689, 9690, 9703, 9738, 9740, 9755, 9782, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9898, 9901, 9909, 9910, 9917, 9920, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 10021, 10024, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10180, 10189, 10193, 10206, 10206, 10208, 10213, 10250, 10253, 10299, 10379, 10394, 10422, 10670, 10671, 10677, 10678, 10683, 10684, 10685, 10695, 10698, 10794, 10799, 10803, 29002, 29014, 29056, 29070, 29107, 29115, 90100, 90124, 90150, 90154, 91003, 95022, 95024, 95100, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95258, 95261, 95333, 95351, 95364, 95387, 95399, 95410, 95473, 95475, 95496, 95504, 95507, 95512, 95524, 95551, 95563, 95614, 95616, 95668, 95688, 95691, 95703, 95704, 95705, 95706, 95707, 95708, 95709, 95710, 95711, 95713, 95716, 95717, 95718, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95728, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95762, 95764, 95765, 95766, 95767, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95786, 95787, 95788, 95789, 95790, 95791, 95794, 95795, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95813, 95815, 95817, 95821, 95824, 95830, 95831, 95832, 95834, 95835, 95837, 95842, 95843, 95845, 95849, 95852, 95853, 95854, 95855, 95857, 95864, 95869, 95874, 95876, 95877, 95881, 95886, 95900, 95901, 95902, 95903, 95904, 95906, 95907, 95910, 95911, 95912, 95915, 95916, 95917, 95918, 95919, 95922, 95924, 95925, 95927, 95928, 95929, 95930, 95934, 95938, 95940, 95941, 95942, 95944, 95946, 95341A, 123002 & 123029.

Distribution pattern

Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 2 of 6

Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Z-1352-2016
Recall number
Z-1352-2016
Initiated
February 05, 2016
Classification
Class II
Status
Terminated
Quantity
324 uNITS

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Code information

Model No. 728306; S/N: 85004, 85010, 85012, 85013, 85014, 85015, 85016, 85017, 85018, 85021, 85022, 85023, 85024, 85025, 85026, 85027, 85028, 85029, 85032, 85033, 85034, 85035, 85036, 85037, 85038, 85039, 85040, 85043, 85044, 85045, 85046, 85047, 85048, 85049, 85050, 85051, 85054, 85055, 85056, 85057, 85058, 85059, 85060, 85061, 85062, 85065, 85066, 85067, 85068, 85069, 85070, 100016, 100018, 100019, 100025, 100037, 100038, 100040, 100044, 100048, 100049, 100050, 100051, 100058, 100062, 100064, 100065, 100070, 100072, 100082, 100084, 100091, 100099, 100101, 100103, 100111, 100113, 100114, 100115, 100119, 100122, 100133, 100134, 100135, 100140, 100144, 100149, 100153, 100161, 100162, 100170, 100178, 100180, 100181, 100184, 100185, 100190, 100191, 100192, 100200, 100214, 100215, 100217, 100221, 100222, 100228, 100231, 100236, 100247, 100260, 100270, 100271, 100273, 100274, 100278, 100280, 100281, 100302, 100304, 100308, 100309, 100310, 100314, 100318, 100325, 100329, 100343, 100346, 100350, 100351, 100356, 100360, 100365, 100368, 100370, 100374, 100393, 100396, 100398, 100399, 100400, 100402, 100405, 100406, 100416, 100423, 100436, 100441, 100446, 100449, 100450, 100452, 100453, 100461, 100462, 100463, 100464, 100465, 100466, 100469, 100472, 100483, 100493, 100494, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100517, 100518, 100520, 100521, 100522, 100600, 100601, 100602, 100603, 100606, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100614, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100628, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100647, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100661, 100662, 100663, 100664, 100665, 100666, 100667, 100668, 100669, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681, 100684, 100685, 100686, 100687, 100688, 100689, 100690, 100691, 100692, 100693, 100695, 100696, 100697, 100698, 100699, 100701, 100702, 100704, 100705, 100706, 100707, 100708, 200004, 200005 & 200098.

Distribution pattern

Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 3 of 6

Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Z-1353-2016
Recall number
Z-1353-2016
Initiated
February 05, 2016
Classification
Class II
Status
Terminated
Quantity
49 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Code information

Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051, 200061, 200063, 200067, 200068, 200074, 200088, 200093, 200097, 200100, 200101, 200105, 200107, 200109, 200111, 200117, 200121, 200127, 200131, 200138, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200209, 200210 & 200211.

Distribution pattern

Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 4 of 6

Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Z-1354-2016
Recall number
Z-1354-2016
Initiated
February 05, 2016
Classification
Class II
Status
Terminated
Quantity
88

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Code information

Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 310022, 310023, 310026, 310032, 310039, 310065, 310077, 310078, 310096, 310102, 310105, 310115, 310125, 310133, 310135, 310157, 310160, 310164, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310245, 310246, 310247, 310248, 310249, 310250, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310287, 310288, 310289, 310290, 310291, 310292, 333002, 333005, 333008, 333010, 333015, 333018, 333021, 333042, 333043, 333051, 333060, 333061, 333064, 333106, 333107, 333108, 333109, 333110, 333112, 333114, 333115, 333116, 333117, 333121, 52062, 52066, 52080, 52081 52082, 52083, 52084, 310286, 333004, 333111, 333113, 333118, 333119 & 333120.

Distribution pattern

Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 5 of 6

Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Z-1355-2016
Recall number
Z-1355-2016
Initiated
February 05, 2016
Classification
Class II
Status
Terminated
Quantity
174 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Code information

Model No. 728323; S/N: 30016, 30023, 30151, 30153, 32000, 32001, 32008, 32012, 32042, 32044, 32057, 32061, 32065, 32067, 32068, 32069, 32076, 32100, 32106, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162, 32163, 32164, 32165, 32166, 32167, 52023, 52028, 52049, 320001, 320003, 320006, 320008, 320010, 320024, 320026, 320029, 320031, 320037, 320054, 320070, 320078 320090, 320092, 320107, 320202, 320207, 320224, 320225, 320226, 320227, 320228, 320229 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248, 320250, 320251, 320252, 320254, 320255, 320256, 320258, 336011, 336012, 336015, 336016, 336018, 336025, 336027, 336028, 336029, 336034, 336040, 336044, 336068, 336072, 336076, 336092, 336100, 336102, 336104, 336142, 336148, 336149, 336150, 336151, 336152, 336153, 336154, 336155, 336156, 336157, 336158, 336159, 336160, 336161, 336162, 336163, 336164, 336166, 336167, 336168, 336170, 336171, 336172, 336173, 336174, 336175, 336176, 336177, 336178, 336180, 336181, 336182, 336183, 336184, 336185, 336186, 336188, 336190, 336192, 336193, 336194, 30035, 320257, 333047, 336165, 336179, 336187, 336189, 336191, 336195, 336196, 336197, 336199 & 336200.

Distribution pattern

Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 6 of 6

Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Z-1356-2016
Recall number
Z-1356-2016
Initiated
February 05, 2016
Classification
Class II
Status
Terminated
Quantity
82 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Code information

Model No. 728326; S/N: 30003, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 32083, 52051, 300004, 300015, 300033, 300037, 300038, 300045, 300054, 300057, 300066, 300068, 300072, 300081, 300082, 300084, 30008, 300091, 300107, 300109, 300120, 300122, 300141, 300142, 300149, 300150, 300156, 300157, 300207, 300208, 300209, 300210, 300211, 30004-1, 1, 3, 941055, 30047, 30049, 300146, 300212, 95742 & 941091.

Distribution pattern

Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.