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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94979

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

Open FDA event record

Event summary

Timeline bucket
July 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DKK Dai-Ichi Shomei Co., Ltd.

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

4 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 4

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

Z-2618-2024
Recall number
Z-2618-2024
Initiated
July 09, 2024
Classification
Class II
Status
Ongoing
Quantity
555 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Code information

Model Number: LED7-LH/7TV-LH; Serial Numbers: 7010002, 7010003, 7010004, 7010005, 7010006, 7030007, 7030008, 7030009, 7030010, 7030011, 7030012, 7030013, 7030014, 7030015, 7030016, 7030017, 7030018, 7030019, 7030020, 7030021, 7040022, 7040023, 7040024, 7040025, 7040026, 7040027, 7040028, 7040029, 7040030, 7040031, 7040032, 7040033, 7040034, 7040035, 7040036, 7040037, 7070039, 7070040, 7070041, 7070042, 7070043, 7070044, 7070045, 7070046, 7070047, 7070048, 7070049, 7070050, 7080053, 7080054, 7080055, 7080056, 7080057, 7080058, 7080059, 7080060, 07080061, 7080062, 7080063, 7080064, 7080065, 7080066, 7080067, 7080068, 7080069, 7080070, 7080071, 7080072, 7080073, 7080074, 7080075, 7080076, 7080077, 7080078, 7080079, 7080080, 7080081, 7090082, 7090083, 7090084, 7090085, 7090086, 7090087, 7090088, 7090089, 7090090, 7090091, 7100092, 7100093, 7100094, 7100095, 7100096, 7100097, 07100098, 7100099, 7100100, 7100101, 7100102, 7100103, 7100104, 7100105, 7100106, 7100107, 7100108, 7100109, 7100110, 7100111, 7110112, 7110113, 7110114, 7110115, 7110116, 7110117, 7110118, 7110119, 7110120, 7110121, 7110122, 7110123, 7110124, 7110125, 7110126, 7110127, 7110128, 7110129, 7110130, 7110131, 7120132, 8010134, 8010135, 8010136, 8010137, 8010138, 8010139, 8010140, 8010141, 8010142, 8010143, 8010144, 8010145, 8010146, 8010147, 8010148, 8010149, 8010150, 8010151, 8010152, 8020153, 8020154, 8020155, 8020156, 8020157, 8020158, 8020159, 8020160, 8020161, 8020162, 8020163, 8020164, 8020165, 8020166, 8020167, 8020168, 8020169, 08020170, 08020171, 08020172, 8020173, 8020174, 8020175, 8020176, 8020177, 8020178, 8020179, 8020180, 8020181, 8020182, 8020183, 8020184, 8020185, 8020186, 8020187, 8020188, 8020189, 8020190, 8020191, 8020192, 8020193, 08020194, 8030195, 8030196, 8030197, 8030198, 8030199, 8030200, 8030201, 8030202, 8030203, 8030204, 8030205, 8030206, 8030207, 8030208, 8030209, 8030210, 8030211, 8030212, 8030213, 8030214, 8030215, 8030216, 8030217, 8030218, 8030219, 8030220, 8030221, 8030222, 8030223, 8030224, 8040225, 8040226, 8040227, 8040228, 8040229, 8040230, 8040231, 8040232, 8040233, 8040234, 8040235, 8040236, 8040237, 8040238, 8040239, 8040240, 8040241, 8040242, 8040243, 8040244, 8040245, 8040246, 8040247, 8050248, 8050249, 8050250, 8050251, 8050252, 8050253, 8050254, 8050255, 8050256, 8050257, 8050258, 8050259, 8050260, 8050261, 8050262, 8050263, 8050264, 8050290, 8050291, 8050292, 8050293, 8050294, 8050295, 8050296, 8050297, 8050298, 8050299, 8050300, 8070301, 8070302, 8070303, 8070304, 8070305, 8070306, 8070307, 8070308, 8070309, 8070310, 8070311, 8070312, 8070313, 8070314, 8070315, 8070316, 8070317, 8070318, 8070319, 8070320, 8080321, 8080322, 8080323, 8080324, 8080325, 8080326, 8080327, 8080328, 8080329, 8080330, 8080331, 8080332, 8080333, 8080334, 8080335, 8080336, 8080337, 8080338, 8080339, 8080340, 8080341, 8080342, 8080343, 8080344, 8080345, 8080346, 8080347, 8080348, 8080349, 8080350, 8090351, 8090352, 8090353, 8090354, 8090355, 8090356, 8090357, 8090358, 8090359, 8090360, 8090361, 8090362, 8090363, 8090364, 8090365, 8100366, 8100367, 8100368, 8100369, 8100370, 8100371, 8100372, 8100373, 8100374, 8100375, 8100376, 8100377, 8100378, 8100379, 8100380, 8100381, 8100382, 8100383, 8100384, 8100385, 8100386, 8100387, 8100388, 8100389, 8100390, 8100391, 8100392, 8100393, 8100394, 8100395, 8100396, 8100397, 8100398, 8110400, 8110401, 8110402, 8110403, 8110404, 8110405, 8110406, 8110407, 8110408, 8120409, 8120410, 8120411, 8120412, 8120413, 8120414, 8120415, 8120416, 8120417, 8120418, 8120419, 8120420, 8120421, 08120422, 8120423, 8120424, 8120425, 8120426, 8120427, 8120428, 8120429, 8120430, 9010431, 9010432, 9010433, 9010434, 9010435, 9010436, 9010437, 9010438, 9010439, 9010440, 9010441, 9010442, 9010443, 9010444, 9010445, 9010446, 9010447, 9010448, 9010449, 9010450, 9020452, 9020453, 9020454, 9020455, 9020456, 9020457, 9020458, 9020459, 9020460, 9020461, 9020462, 9020463, 9020464, 9020465, 9020466, 9020467, 9020468, 9020469, 9020470, 9020471, 9020472, 9020473, 9020474, 9020475, 9020476, 9020477, 9030478, 9030479, 9030480, 9030481, 9030482, 9030483, 9030484, 9030486, 9030487, 9030488, 9030489, 9030490, 9030491, 9030492, 9030493, 9030494, 9030495, 9030496, 9030497, 9030498, 9030499, 9030500, 9030501, 9030502, 9030503, 9030504, 9030505, 9040506, 9040507, 9060509, 9060510, 9060511, 9060512, 9060513, 9060514, 9060515, 9060516, 9070517, 9070518, 9070519, 9070520, 9070521, 9080531, 9080532, 9080533, 9080534, 9080535, 9080536, 9080537, 9080538, 9080539, 9080540, 9080541, 9120543, 9120544, 10010545, 10010546, 10010547, 10010548, 10010549, 10020055, 10020551, 10020552, 10020553, 10020554, 10020555, 10020556, 10020557, 10030558, 10030559, 10030560, 10030561, 10030562, 10030563, 10030564, 10030565, 10030566, 10030567, 10040568, 10040569, 10040570, 10040571, 10040572, 10040573, 10050574, 10050575, 10050576, 10050577, 10050578, 10050579, 10080580, 10080581, 10080582, 10080583, 10080584, 10090585, 10090586, 10090587, 10090588, 10090589, 10090590, 10090591, 12070597, 12070598, 12080599, 12080600, 12080601, 12080602, 12080603, 12080604,

Distribution pattern

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

device · product 2 of 4

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

Z-2619-2024
Recall number
Z-2619-2024
Initiated
July 09, 2024
Classification
Class II
Status
Ongoing
Quantity
822 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Code information

Model Number: AUR7-LH/7TV-LH; Serial Numbers: 09010002, 9020003, 9020004, 9020007, 9020008, 9020009, 9020010, 9020011, 9020012, 9020013, 9020014, 9020015, 9020016, 9030017, 9030018, 9030019, 9030020, 9030021, 9030022, 9040023, 9040024, 9040025, 9040026, 9040027, 9040028, 9040029, 9040030, 9040031, 9040032, 9040033, 9040034, 9040035, 9040036, 9040037, 9040038, 9040039, 9040040, 9040041, 9040042, 9050043, 9050044, 9050045, 9050046, 9050047, 9050048, 9050049, 9050050, 9050051, 9050052, 9050053, 9050054, 9050055, 9050056, 9050057, 9050058, 9050059, 9050060, 9050061, 9050062, 9050063, 9050064, 9050065, 9050066, 9050067, 9050068, 9050069, 9050070, 9050071, 9050072, 9060073, 9060074, 9060075, 9060076, 9060077, 9060078, 9060079, 9060080, 9060081, 9060082, 9060083, 9060084, 9060085, 9060086, 9060087, 9060088, 9060089, 9060090, 9060091, 9060092, 9080093, 9080094, 9080095, 9080097, 9080098, 9080099, 9080100, 9080101, 9080102, 9080104, 9080105, 9080106, 9080107, 9090108, 9090109, 9090110, 9090111, 9090112, 9090113, 9090114, 9090115, 9090116, 9090117, 9090118, 9090119, 9110120, 9110121, 9110122, 9110123, 9110124, 9110125, 9110126, 9110127, 9110128, 9110129, 9110130, 9120131, 9120132, 9120133, 9120134, 9120135, 9120136, 9120137, 9120138, 9120139, 9120140, 9120141, 09120142, 9120143, 9120144, 10010145, 10010146, 10010147, 10010148, 10010149, 10010150, 10010151, 10010152, 10010153, 10010154, 10010155, 10010156, 10010157, 10010158, 10020159, 10020160, 10020161, 10020162, 10020163, 10020164, 10020165, 10020166, 10030167, 10030168, 10030169, 10030170, 10030171, 10030172, 10030173, 10030174, 10030175, 10040176, 10040177, 10040178, 10040179, 10040180, 10040181, 10040182, 10040183, 10040184, 10040185, 10040186, 10040187, 10040188, 10040189, 10040190, 10040191, 10040192, 10040193, 10040194, 10040195, 10040196, 10040197, 10040198, 10040199, 10040200, 10040201, 10040202, 10040203, 10040204, 10040205, 10050206, 10050207, 10050208, 10050209, 10050210, 10050211, 10050212, 10050213, 10050214, 10050215, 10050216, 10050217, 10050218, 10050219, 10050220, 10050221, 10050222, 10050223, 10050224, 10050225, 10050226, 10050227, 10050228, 10050229, 10050230, 10050231, 10050232, 10050233, 10050234, 10050235, 10050236, 10050237, 10050238, 10050239, 10050240, 10050241, 10050242, 10060243, 10060244, 10060245, 10060246, 10060247, 10060248, 10060249, 10060250, 10060251, 10060252, 10060253, 10060254, 10060255, 10070256, 10070257, 10070258, 10070259, 10070260, 10070261, 10070262, 10070263, 10070264, 10080265, 10080266, 10080267, 10080268, 10080269, 10080270, 10080271, 10080272, 10080273, 10080274, 10080275, 10080276, 10080277, 10080290, 10090278, 10090279, 10090280, 10090281, 10090282, 10090283, 10090284, 10090285, 10090286, 10090287, 10090288, 10090289, 10090291, 10100292, 10100293, 10100294, 10100295, 10110296, 10110297, 10110298, 10110299, 10110300, 10110301, 10110302, 11010303, 11010304, 11010305, 11010306, 11010307, 11010308, 11010309, 11010310, 11010311, 11010312, 11010313, 11010314, 11010315, 11010316, 11010317, 11010318, 11010319, 11010320, 11020321, 11020322, 11020323, 11020324, 11020325, 11020326, 11020327, 11020328, 11020329, 11020330, 11020331, 11020332, 11020333, 11020334, 11020335, 11030336, 11030337, 11030338, 11030339, 11030340, 11030341, 11030342, 11030343, 11030344, 11030345, 11030346, 11030347, 11030348, 11030349, 11030350, 11030351, 11030352, 11030353, 11040354, 11040355, 11040356, 11040357, 11040358, 11040359, 11040360, 11040361, 11040362, 11040363, 11040364, 11040365, 11040366, 11040367, 11040368, 11040369, 11040370, 11040371, 11040372, 11040373, 11050374, 11050375, 11050376, 11050377, 11050378, 11060379, 11060380, 11060381, 11060382, 11060383, 11060384, 11060385, 11060386, 11060387, 11060388, 11060389, 11060390, 11060391, 11060392, 11060393, 11060394, 11060395, 11060396, 11060397, 11060398, 11060399, 11060400, 11060401, 11060402, 11060403, 11060404, 11060405, 11060406, 11060407, 11060408, 11060409, 11060410, 11060411, 11060412, 11070413, 11070414, 11070415, 11070416, 11070417, 11070418, 11070419, 11070420, 11070421, 11070422, 11080423, 11080424, 11080425, 11080426, 11080427, 11080428, 11080429, 11080430, 11080431, 11080432, 11080433, 11080434, 11090435, 11090436, 11090437, 11090438, 11090439, 11090440, 11090441, 11090442, 11090443, 11090444, 11090445, 11090446, 11090447, 11090448, 11090449, 11090450, 11090451, 11090452, 11090453, 11090454, 11090455, 11100456, 11100457, 11100458, 11100459, 11100460, 11100461, 11110463, 11110464, 11110465, 11110466, 11110467, 11110468, 11110469, 11110470, 11110471, 11110472, 11110473, 11110474, 11110475, 11110476, 11110477, 11110478, 11110479, 11110480, 11110481, 11110482, 11110483, 11110484, 11110485, 11110486, 11110487, 11110488, 11110489, 11120490, 11120491, 11120492, 11120493, 11120494, 11120495, 11120496, 11120497, 11120498, 11120499, 11120500, 11120501, 11120502, 11120503, 11120504, 12010505, 12010506, 12010507, 12010508, 12010509, 12010510, 12010511, 12010512, 12010513, 12010514, 12020515, 12020516, 12020517, 12020518, 12020519, 12020520, 12020521, 12020522, 12020523, 12020524, 12020525, 12020526, 12020527, 12020528, 12020529, 12040530, 12040531, 12040532, 12040533, 12040534, 12040535, 12040536, 12040537, 12040538, 12040539, 12040540, 12040541, 12040542, 12040543, 12040544, 12040545, 12040546, 12040547, 12040548, 12040549, 12040550, 12040551, 12040552, 12040553, 12040554, 12040556, 12040557, 12040558, 12040559, 12050560, 12050561, 12050562, 12050563, 12050564, 12050565, 12050566, 12050567, 12050568, 12050569, 12050570, 12050571, 12050572, 12060573, 12060574, 12060575, 12060576, 12060577, 12060578, 12060579, 12060580, 12060581, 12060582, 12060583, 12060584, 12060585, 12060586, 12060587, 12070588, 12070589, 12070590, 12070591, 12070592, 12070593, 12070594, 12070595, 12070596, 12070597, 12070598, 12080599, 12080600, 12080601, 12080602, 12080603, 12080604, 12080605, 12080606, 12080607, 12080608, 12080609, 12080610, 12080611, 12080612, 12080613, 12080614, 12080615, 12080616, 12080617, 12080618, 12080619, 12080620, 12080621, 12080622, 12080623, 12080624, 12080625, 12080626, 12080627, 12080628, 12080629, 12080630, 12080631, 12090632, 12090633, 12090634, 12090635, 12090636, 12090637, 12090638, 12090639, 12090640, 12090641, 12090642, 12090643, 12100644, 12100645, 12100646, 12100647, 12100648, 12100649, 12100650, 12100651, 12100652, 12100653, 12100654, 12100655, 12100832, 12110656, 12110657, 12110658, 12110659, 12110660, 12110661, 12110662, 12110663, 12110664, 12110665, 12110666, 12110667, 12110668, 12110669, 12110670, 12110671, 12110672, 12110673, 12110674, 12110675, 12110676, 12110677, 12110678, 12110679, 12110680, 12110681, 12110682, 12110683, 12110684, 12110685, 12120686, 12120687, 12120688, 12120689, 12120690, 12120691, 12120692, 12120693, 12120694, 12120695, 12120696, 12120697, 13010698, 13010699, 13010700, 13010701, 13010702, 13010703, 13010704, 13010705, 13010706, 13010707, 13010708, 13010709, 13010710, 13010711, 13010712, 13020713, 13020714, 13020715, 13020716, 13020717, 13020718, 13020719, 13020720, 13020721, 13020722, 13020723, 13020724, 13020725, 13020726, 13020727, 13020728, 13020729, 13020730, 13020731, 13020732, 13030735, 13030736, 13030737, 13030738, 13030739, 13030740, 13030741, 13030742, 13030743, 13030744, 13030745, 13030746, 13030747, 13030748, 13030749, 13030750, 13030751, 13030752, 13030753, 13060754, 13060755, 13060756, 13060757, 13060758, 13060759, 13060760, 13060761, 13060762, 13060763, 13060764, 13060765, 13060766, 13060767, 13060768, 13060769, 13060770, 13070771, 13070772, 13070773, 13070774, 13070775, 13070776, 13070777, 13070778, 13070779, 13070780, 13070781, 13070782, 13070783, 13070784, 13070785, 13070786, 13070787, 13080788, 13080789, 13080790, 13080791, 13080792, 13080793, 13080794, 13080795, 13080796, 13080797, 13100798, 13100799, 13100800, 13100801, 13100802, 13100803, 13100804, 13100805, 13100806, 13100807, 13100808, 13100809, 13100810, 13100811, 13100812, 13100813, 13100814, 13100815, 13100816, 13100817, 13100818, 13100819, 13100820, 13100821, 13100822, 13100823, 13100824, 13100825, 13100826, 13100827, 13100828, 20040831, 08120001 (PROTO),

Distribution pattern

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

device · product 3 of 4

Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

Z-2620-2024
Recall number
Z-2620-2024
Initiated
July 09, 2024
Classification
Class II
Status
Ongoing
Quantity
293 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Code information

Model Number: AUT7-LH/TV-LH; Serial Numbers: 13040011, 13040012, 13040013, 13040014, 13040015, 13040016, 13040017, 13040018, 13040019, 13040020, 13040021, 13040022, 13040023, 13040024, 13070025, 13070026, 13070027, 13070028, 13070029, 13070030, 13070031, 13070032, 13070033, 13070034, 13070035, 13070036, 13070037, 13070038, 13070039, 13070040, 13070041, 13070042, 13070043, 13080044, 13080045, 13080046, 13080047, 13080048, 13080049, 13080050, 13080051, 13080052, 13080053, 13090054, 13090055, 13090056, 13090057, 13090058, 13090059, 13090060, 13090061, 13090062, 13090063, 13090064, 13090065, 13090066, 13090067, 13090068, 13090069, 13090070, 13090071, 13090072, 13090073, 13090074, 13090075, 13090076, 13090077, 13100078, 13100079, 13100080, 13100081, 13100082, 13100083, 13100084, 13100085, 13100086, 13100087, 13100088, 13100089, 13100090, 13100091, 13100092, 13100093, 13100094, 13100095, 13100096, 13100097, 13110098, 13110099, 13110100, 13110101, 13110102, 13110103, 13110104, 13110105, 13110106, 13110107, 13110108, 13110109, 13110110, 13110111, 13120112, 13120113, 13120114, 14010115, 14010116, 14010117, 14010118, 14010119, 14010120, 14010121, 14010122, 14010123, 14010124, 14010125, 14010126, 14010127, 14010128, 14010129, 14010130, 14010131, 14010132, 14010133, 14020134, 14020135, 14020136, 14020137, 14020138, 14020139, 14020140, 14020141, 14020142, 14020143, 14020144, 14020145, 14020146, 14020147, 14020148, 14020149, 14020150, 14020151, 14020152, 14020153, 14030154, 14030155, 14030156, 14030157, 14030158, 14030159, 14030160, 14030161, 14030162, 14030163, 14030164, 14030165, 14030166, 14030167, 14030168, 14030169, 14030170, 14030171, 14030172, 14030173, 14040174, 14040175, 14040176, 14040177, 14040178, 14040179, 14040180, 14040181, 14040182, 14040183, 14040184, 14040185, 14040186, 14040187, 14040188, 14040189, 14040190, 14040191, 14040192, 14040193, 14040194, 14040195, 14040196, 14040197, 14040198, 14040199, 14040200, 14040201, 14040202, 14040203, 14040204, 14040205, 14040206, 14040207, 14040208, 14040209, 14040210, 14040211, 14040212, 14040213, 14050214, 14050215, 14050216, 14050217, 14050218, 14050219, 14050220, 14050221, 14050222, 14050223, 14050224, 14050225, 14050226, 14050227, 14050228, 14050229, 14050230, 14050231, 14050232, 14050233, 14050234, 14050235, 14050236, 14050237, 14050238, 14050239, 14050240, 14050241, 14050242, 14050243, 14050244, 14050245, 14050246, 14050247, 14050248, 14050249, 14050250, 14050251, 14050252, 14050253, 14060254, 14060255, 14060256, 14060257, 14060258, 14070259, 14070260, 14070261, 14070262, 14070263, 14070264, 14070265, 14070266, 14070267, 14070268, 14070269, 14070270, 14070271, 14070272, 14070273, 14070274, 14070275, 14070276, 14070277, 14070278, 14070279, 14070280, 14070281, 14070282, 14070283, 14070284, 14070285, 14070286, 14070287, 14070288, 14080289, 14080290, 14080291, 14080292, 14080293, 14080294, 14080295, 14080296, 14080297, 14080298, 14080299, 14080300, 14080301, 14080302, 14080303,

Distribution pattern

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

device · product 4 of 4

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

Z-2621-2024
Recall number
Z-2621-2024
Initiated
July 09, 2024
Classification
Class II
Status
Ongoing
Quantity
538 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Code information

Model Number: AUA7-LH/7TV-LH; UDI-DI: 10841736100025; Serial Numbers: 07120133, 2015-03-0001, 2015-03-0002, 2015-03-0003, 2015-03-0004, 2015-03-0005, 2015-03-0006, 2015-03-0007, 2015-03-0008, 2015-03-0009, 2015-03-0010, 2015-04-0011, 2015-04-0012, 2015-04-0013, 2015-04-0014, 2015-04-0015, 2015-04-0016, 2015-04-0017, 2015-04-0018, 2015-04-0019, 2015-04-0020, 2015-04-0021, 2015-04-0022, 2015-04-0023, 2015-04-0024, 2015-04-0025, 2015-05-0026, 2015-05-0027, 2015-05-0028, 2015-05-0029, 2015-05-0030, 2015-05-0031, 2015-05-0032, 2015-05-0033, 2015-05-0034, 2015-05-0035, 2015-05-0036, 2015-05-0037, 2015-05-0038, 2015-05-0039, 2015-05-0040, 2015-06-0041, 2015-06-0042, 2015-06-0043, 2015-06-0044, 2015-06-0045, 2015-06-0046, 2015-06-0047, 2015-06-0048, 2015-06-0049, 2015-06-0050, 2015-06-0051, 2015-06-0052, 2015-06-0053, 2015-06-0054, 2015-06-0055, 2015-07-0056, 2015-07-0057, 2015-07-0058, 2015-07-0059, 2015-07-0060, 2015-07-0061, 2015-07-0062, 2015-07-0063, 2015-07-0064, 2015-07-0065, 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Distribution pattern

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.