MAGNETOM Cima.X Upgrade. Model Number: 11689304.
FDA Recall #Z-0431-2026 — Class I — October 1, 2025
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.
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
4 system (1 US; 3 OUS)
Distribution
US distribution to California. International distribution to Australia, Germany, Great Britian.
Code Information
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated