Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the

Summary

The FDA issued a Class II for Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aur by DKK Dai-Ichi Shomei Co., Ltd.. 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,.

Details

Product Description

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.

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, 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13100816, 13100817, 13100818, 13100819, 13100820, 13100821, 13100822, 13100823, 13100824, 13100825, 13100826, 13100827, 13100828, 20040831, 08120001 (PROTO),

Quantity Affected: 822 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-07-09

Company