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Nidek Inc recalls GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for us
Recalled August 20, 2014 · FDA recall Z-2120-2014 · Nidek
Hazard
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation, · FDA Class II
Units
567 units
Sold at
USA (nationwide) Distribution
Description
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
Product
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.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →