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.
This recall is currently active, issued August 14, 2024. It was issued by Dkk Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan.
- Recall Initiated
- July 9, 2024
- Posted
- August 14, 2024
- Recall Number
- Z-2619-2024
- Quantity
- 822 units
- Official Source
- View on FDA website ↗
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.
Distribution
Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
Lot / Code Info
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).
Root Cause
Process control
Action Taken
On July 9, 2024 URGENT: Aurora 7 Lighthead Series RECALL letters were sent to customers. Actions to be taken by the customer: Contact the end users and tell them to discontinue the use of the product. Please send an acknowledgement letter or email to Dai-ichi Shomei to let us know that you have received this Field Action Advisory Notice within 3 days after you receive the Notice. Actions to be Taken by the Manufacturer: The physical correction will be announced later. Contact information for questions: email info@hospilite.co.jp