The Recall Desk
SevereFDA (Devices)·Z-2656-2025·Announced 2025-10-08

MAGNETOM Cima.X MRI System Recall for Potential Helium Leak Risk

Siemens is recalling the MAGNETOM Cima.X MRI system worldwide due to potential ice blockage in the magnet venting system. During a quench, helium gas may fail to escape, potentially causing pressure buildup and leak into the scanning room.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. Under FDA regulations, Class I recalls indicate a serious health hazard where use of the defective product can cause serious adverse health consequences or death. Although no injuries or illnesses have been reported to date, the Class I classification itself requires a Severe severity rating.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the MAGNETOM Cima.X (DE), Model Number 11647158, an MRI system. The recall affects 22 units distributed worldwide, including throughout the United States.

The recall is due to a potential defect in the magnet venting system. Ice blockage may form or currently exist within this system. If a quench occurs, helium gas may be unable to escape through the designed venting paths. This could cause pressure to build up within the helium containment system.

The pressure buildup could rupture the helium containment system, potentially resulting in helium leaking into the scanning room. This constitutes a serious potential health hazard to patients and staff.

Healthcare facilities with this equipment should contact Siemens Medical Solutions USA, Inc. immediately for further guidance on remediation and resolution options.

The recalled product

Product
MAGNETOM Cima.X (DE). Model Number: 11647158.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
  • ice-blockage
  • pressure-buildup
  • helium-leak
  • rupture

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029
  • (01)04056869975221(21)213006
  • (01)04056869975221(21)213062
  • (01)04056869975221(21)213043
  • (01)04056869975221(21)213041
  • (01)04056869975221(21)213034
  • (01)04056869975221(21)213035
  • (01)04056869975221(21)213028
  • (01)04056869975221(21)213031
  • (01)04056869975221(21)213018
  • (01)04056869975221(21)213061
  • (01)04056869975221(21)213005
  • (01)04056869975221(21)213021
  • (01)04056869975221(21)213022
  • (01)04056869975221(21)213056
  • (01)04056869975221(21)213030
  • (01)04056869975221(21)213039
  • (01)04056869975221(21)213025
  • (01)04056869975221(21)213063
  • (01)04056869975221(21)213057

Distribution

Distributed nationwide across the United States.

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