Device recall
Z-0478-2022: OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
FDA device recall · Class II · Haag-Streit USA Inc
Key facts
| Recall number (Z-number) | Z-0478-2022 |
|---|---|
| Recall event | 89176 |
| Product | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 |
| Product code | OBO |
| Recalling firm | Haag-Streit USA Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K142953 |
| FEI number | 1000136533 |
At a glance
- 1–9 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