Z-0431-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- October 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 system (1 US; 3 OUS)
Product Description
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Reason for Recall
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.
Distribution Pattern
US distribution to California. International distribution to Australia, Germany, Great Britian.
Code Information
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.