Recall Z-2656-2025— Siemens Medical Solutions USA, Inc
Class I · Ongoing
Class I FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: MAGNETOM Cima.X (DE). Model Number: 11647158.. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-08-28
- Firm location
- Malvern, PA, United States
Product description
MAGNETOM Cima.X (DE). Model Number: 11647158.
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, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.