Device recall
Z-0826-2022: CARA (Computer Assisted Retinal Analysis), Product ID…
FDA device recall · Class II · Diagnos Inc
Key facts
| Recall number (Z-number) | Z-0826-2022 |
|---|---|
| Recall event | 89715 |
| Product | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 |
| Product code | NFJ |
| Recalling firm | Diagnos Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2024 |
| 510(k) numbers | K110869 |
| FEI number | 3009422347 |
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