Home / Recalls / Medical Devices
Nidek Inc recalls Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20;
Recalled July 22, 2015 · FDA recall Z-2068-2015 · Nidek
Hazard
Accessories to the GYC-1000 laser were missing Laser Aperture labels. · FDA Class II
Units
W020 - 1 unit; 0Z20- 6 units
Sold at
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Description
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Product
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; 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 →