FDA Device recall Z-2654-2025
Biograph mMR. Model Number: 10433372
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of Biograph mMR. Model Number: 10433372 by Siemens Medical Solutions Usa, citing 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 desi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2654-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-28 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Biograph mMR. Model Number: 10433372.
Reason
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, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Identifiers
| code_info | Model Number: 10433372. UDI Number: (01)04056869006741(21)151032, (01)04056869006741(21)151057, (01)04056869006741(21)5…Model Number: 10433372. UDI Number: (01)04056869006741(21)151032, (01)04056869006741(21)151057, (01)04056869006741(21)510535, (01)04056869006741(21)151034, (01)04056869006741(21)51003, (01)04056869006741(21)151021, (01)04056869006741(21)51055, (01)04056869006741(21)151013, (01)04056869006741(21)51064, (01)04056869006741(21)151044, (01)04056869006741(21)51038, (01)04056869245188(21)51006, (01)04056869006741(21)51030, (01)04056869006741(21)151004, (01)04056869006741(21)51022, (01)04056869006741(21)151049, (01)04056869006741(21)51007, (01)04056869006741(21)151045, (01)04056869006741(21)51032, (01)04056869006741(21)51057, (01)04056869006741(21)51015, (01)04056869006741(21)151025, (01)04056869006741(21)51048, (01)04056869006741(21)51062, (01)04056869006741(21)51010, (01)04056869006741(21)51051. Serial Numbers: 151032, 151057, 51053, 151034, 51003, 151021, 51055, 151013, 51064, 151044, 51038, 51006, 51030, 151004, 51022, 151049, 51007, 151045, 51032, 51057, 51015, 151025, 51048, 51062, 51010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2654-2025%22
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