Recall Z-0431-2026 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
| Date | Nov 12, 2025 (initiated Oct 1, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare notified consignees on about 10/01/2025 via "URGENT: MEDICAL DEVICE CORRECTION" letter dated 08/27/2025. Consignees were informed that Siemens Customer Service Organization will conduct an inspection of affected units to address the issue. If customers identify issues, they are cautioned to not reboot the system, to call their local Siemens Healthineers service organization, and grant access to the system for the inspection. Siemens is preparing to inspect devices and, if necessary, perform a correction to resolve the issue. Consignees were also instructed to ensure all user |
| Quantity | 4 system (1 US; 3 OUS) |
| Distribution | US distribution to California. International distribution to Australia, Germany, Great Britian. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231587 | MAGNETOM Cima.X Siemens Medical Solutions USA, Inc., Dec 18, 2023 |