FDA Device recall Z-2657-2025
MAGNETOM Connectom.X. Model Number: 11371480
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of MAGNETOM Connectom.X. Model Number: 11371480 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-2657-2025 |
| 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 Connectom.X. Model Number: 11371480.
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: 11371480. UDI Numbers: N/A. Serial Numbers: 237551. |
|---|
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-2657-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.