FDA Device recall Z-2668-2025
MAGNETOM Vida Fit
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of MAGNETOM Vida Fit 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-2668-2025 |
| 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
MAGNETOM Vida Fit. Model Number: 11410481.
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: 11410481. UDI Numbers: (01)04056869245188(21)202129, (01)04056869245188(21)202025, (01)04056869245188(21)…Model Number: 11410481. UDI Numbers: (01)04056869245188(21)202129, (01)04056869245188(21)202025, (01)04056869245188(21)202139, (01)04056869245188(21)202016, (01)04056869245188(21)202051, (01)04056869245188(21)202055, (01)04056869245188(21)202114, (01)04056869245188(21)202119, (01)04056869245188(21)202013, (01)04056869245188(21)202050, (01)04056869245188(21)202102, (01)04056869245188(21)202160, (01)04056869245188(21)202127, (01)04056869245188(21)202071, (01)04056869245188(21)202078, (01)04056869245188(21)202123, (01)04056869245188(21)202082, (01)04056869245188(21)202107, (01)04056869245188(21)202031, (01)04056869245188(21)202110, (01)04056869245188(21)202108, (01)04056869245188(21)202101, (01)04056869245188(21)202093, (01)04056869245188(21)202104, (01)04056869245188(21)202028, (01)04056869245188(21)202026, (01)04056869245188(21)202076, (01)04056869245188(21)202142, (01)04056869245188(21)202125, (01)04056869245188(21)202155, (01)04056869245188(21)202084, (01)04056869245188(21)202151, (01 |
|---|
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-2668-2025%22
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