FDA Device recall Z-2067-2015
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indic…
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indic… 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-2067-2015 |
| 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
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: 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 GYC4DD-1 |
|---|
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-2067-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.