Device recall
Z-0223-2015: Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-0223-2015 |
|---|---|
| Recall event | 69508 |
| Product | Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control. |
| Product code | LZS |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2014 |
| PMA numbers | P970053 |
| FEI number | 2936921 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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