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.
Enforcement
- Recall Number
- Z-2618-2024
- Event ID
- 94979
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DKK Dai-Ichi Shomei Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 21, 2024
- Initiation Date
- July 9, 2024
- Classification Date
- August 14, 2024
- Address
- 1 Chome 32-26, Sakashita, Itabashi, N/A, Japan
Description
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.
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.
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, 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Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
555 units