Device recall
Z-2654-2025: Biograph mMR. Model Number: 10433372.
FDA device recall · Class I · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-2654-2025 |
|---|---|
| Recall event | 97530 |
| Product | Biograph mMR. Model Number: 10433372. |
| Product code | OUO |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K200213 |
| FEI number | 2240869 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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