Reported Aug 20, 2014 · Terminated
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use…
Nidek Inc.
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: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
- Lot codes and dates
- ModelGYC-1000
- Serial numbers
553 of 553 codes
100181003910040100411004210043100441004510046100471004810063100641006610067100681007210073100741007510079100801008110082100831008410085100861008710088101081010910110101111011210113101141011510116101171014610147101481014910150101511015210153101541015510162102081020910212102131022210225102261023810239
- Amount recalled
- 567 units
Where it was sold
- Nationwide
Why it was recalled
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
This product could cause temporary or reversible health problems — stop using it.
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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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