Device recall
Z-2068-2015: Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-2068-2015 |
|---|---|
| Recall event | 71527 |
| 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… |
| Product code | GEX |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 14, 2015 |
| 510(k) numbers | K032085, K133358 |
| FEI number | 2936921 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database