Reported Aug 21, 2024 · Ongoing
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the…
DKK Dai-Ichi Shomei Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DKK Dai-Ichi Shomei Co., Ltd. · 1 Chome 32-26 · Itabashi · N/A
Is this the product you have?
- Aurora Series, Aurora 7 lighthead
- ModelsLED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site
- Lot codes and dates
- Model NumberLED7-LH/7TV-LH
- Serial Numbers
555 of 555 codes
7010002701000370100047010005701000670300077030008703000970300107030011703001270300137030014703001570300167030017703001870300197030020703002170400227040023704002470400257040026704002770400287040029704003070400317040032704003370400347040035704003670400377070039707004070700417070042707004370700447070045707004670700477070048707004970700507080053708005470800557080056708005770800587080059708006007080061708006270800637080064
- Amount recalled
- 555 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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