Device recall
Z-1367-2015: YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-1367-2015 |
|---|---|
| Recall event | 70571 |
| Product | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. |
| Product code | LXS |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2015 |
| 510(k) numbers | K893987 |
| FEI number | 2936921 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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