Recall Z-2120-2014 ยท GEX Powered Laser Surgical Instrument
Nidek Inc
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.
| Date | Aug 13, 2014 (initiated May 16, 2014) |
| Status | Terminated |
| Reason | Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation, |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Nidek sent an Medical Device Correction Notifications dated May 16, 2014, informing doctors of the lack of the Laser Aperture Label for GYC-1000 Green Laser Photocoagulator System. Letters included a Aperture label and instruction/illustration on where to affix it to the device. A response form is to be completed and returned indicating that they read the correction information and have affixed the label on the GYC-1000 device as instructed. Questions may be directed to Nidek Customer service at 1-800-223-9044 Monday - Friday from 8 am to 5 pm PST. CDRH approves the CAP subject to the fo |
| Quantity | 567 units |
| Distribution | USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 Nidek, Inc., Oct 3, 2003 |