Drug recall
Biograph mMR. Model Number: 10433372.
FDA recall event 97530 · Class I · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 97530 |
|---|---|
| Recall numbers | Z-2654-2025, Z-2655-2025, Z-2656-2025, Z-2657-2025, Z-2658-2025, Z-2659-2025, Z-2660-2025, Z-2661-2025, Z-2662-2025, Z-2663-2025, Z-2664-2025, Z-2665-2025 and 3 more |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | Biograph mMR. Model Number: 10433372., BIOGRAPH One (DE). Model Number: 11689172., MAGNETOM Cima.X (DE). Model Number: 11647158., MAGNETOM Connectom.X. Model Number: 11371480., MAGNETOM Lumina (DE). Model Number: 11344916. and 10 more |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths… |
| Initiation date | Aug 28, 2025 |
| Report date | Oct 8, 2025 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: