Recall
FDAHealthOctober 1, 2025

Siemens Medical Solutions USA, Inc — MAGNETOM Cima.X Upgrade. Model Number: 11689304.

⚠️ 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.

Is this relevant to me?

Geography
US
Source agency
FDA
Category
Health
Published
October 1, 2025

US distribution to California. International distribution to Australia, Germany, Great Britian.

What's affected?

Product
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Lot code
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.

Additional details

Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 4 system (1 US; 3 OUS).

View original FDA notice →

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