Device recall
Z-1348-2018: AUTO REF/KERATOMETER ARK-1s
FDA device recall · Class II · Nidek Inc.
Key facts
| Recall number (Z-number) | Z-1348-2018 |
|---|---|
| Recall event | 79553 |
| Product | AUTO REF/KERATOMETER ARK-1s |
| Product code | HKO |
| Recalling firm | Nidek Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2019 |
| FEI number | 2936921 |
At a glance
- None 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