Device recall
Z-1161-06: OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners…
FDA device recall · Class II · bioMerieux Inc
Key facts
| Recall number (Z-number) | Z-1161-06 |
|---|---|
| Recall event | 35518 |
| Product | OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D |
| Product code | MDB |
| Recalling firm | bioMerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2008 |
| FEI number | 1950204 |
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