FDA Device recall Z-2068-2015
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System by Nidek, citing accessories to the GYC-1000 laser were missing Laser Aperture labels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2068-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-25 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | CA, IL, MA, MN, MO, NE, NJ, NY, OR, RI, TX, UT, WA, WI |
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.
Reason
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Identifiers
| code_info | Model GYC4EP-01 0W02 and GYC4EP-1 0Z20; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2068-2015%22
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