The Recall Desk
SevereFDA (Devices)·Z-2668-2025·Announced 2025-10-08

MRI Scanner Helium Venting System May Leak Due to Ice Blockage

Siemens MAGNETOM Vida Fit MRI scanners may develop ice blockages in the helium venting system. During a quench event, blocked vents could cause helium pressure buildup and rupture, leading to helium leaks 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: FDA Class I classification mandates a minimum score of 4. Although no injuries have been reported, the potential for helium system rupture and indoor helium leaks poses a serious safety hazard to scanning room occupants and staff.

Plain-English summary

Siemens Medical Solutions is recalling 41 MAGNETOM Vida Fit MRI scanners (Model 11410481) worldwide due to a potential ice blockage in the helium venting system.

The magnet venting system is designed to allow helium gas to escape during a quench event (emergency shutdown). Ice may form in or already exist within the venting pathways. If ice blocks these pathways, helium cannot escape as designed, causing pressure to build up within the helium containment system. This pressure buildup could ultimately rupture the helium containment, potentially releasing helium into the scanning room.

Healthcare facilities using the affected MAGNETOM Vida Fit scanners with Model Number 11410481 and the listed UDI numbers or serial numbers are advised to contact Siemens Medical Solutions USA, Inc for inspection instructions and remediation procedures. Operators should be alert to any signs of venting system blockage or damage.

The recalled product

Product
MAGNETOM Vida Fit. Model Number: 11410481.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
  • helium-leak
  • pressure-buildup
  • ice-blockage

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: 11410481. UDI Numbers: (01)04056869245188(21)202129
  • (01)04056869245188(21)202025
  • (01)04056869245188(21)202139
  • (01)04056869245188(21)202016
  • (01)04056869245188(21)202051
  • (01)04056869245188(21)202055
  • (01)04056869245188(21)202114
  • (01)04056869245188(21)202119
  • (01)04056869245188(21)202013
  • (01)04056869245188(21)202050
  • (01)04056869245188(21)202102
  • (01)04056869245188(21)202160
  • (01)04056869245188(21)202127
  • (01)04056869245188(21)202071
  • (01)04056869245188(21)202078
  • (01)04056869245188(21)202123
  • (01)04056869245188(21)202082
  • (01)04056869245188(21)202107
  • (01)04056869245188(21)202031
  • (01)04056869245188(21)202110

Distribution

Distributed nationwide across the United States.

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