Recall Z-2068-2015 ยท GEX Powered Laser Surgical Instrument
Nidek Inc
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.
| Date | Jul 14, 2015 (initiated Mar 25, 2015) |
| Status | Terminated |
| Reason | Accessories to the GYC-1000 laser were missing Laser Aperture labels. |
| Root cause | Error in labeling |
| Action | Nidek sent Recall Notifications to doctors on March 31, 2015, by Federal Express. Letters were specific to the accessory involved. NIDEK detected that the laser aperture label has not been affixed on the delivery unit of GYC-1000, Green Laser Photocoagulator System and the device does not meet FDA regulation 21 CFR Subchapter J. In order to comply with FDA regulation, Nidek requests that the customer affix the enclosed laser aperture label to the Dual Delivery 4DD-1 of GYC-1000, according to the instructions attached. Please see the enclosed Laser Aperture label, instruction for affixing to |
| Quantity | W020 - 1 unit; 0Z20- 6 units |
| Distribution | US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI. |
| FDA record | Open on fda.gov |