DKK Dai-Ichi Shomei Co., Ltd.: 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.

Recall number

Z-2619-2024

Recalling firm

DKK Dai-Ichi Shomei Co., Ltd.

Product

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.

Status

Open, Classified

Initiated

2024-07-09

Posted

2024-08-14

Terminated

not on file

Reason

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.

Root cause

Process control

Action

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

Quantity

822 units

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, serial or model codes

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, 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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).

510(k) numbers

["K071698"]

PMA numbers

not on file

Product code

FSY

Firm FEI

3006437518

Firm city

Itabashi

Firm state

Sakashita

Firm country

Japan

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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