The Recall Desk
SevereFDA (Devices)·Z-2667-2025·Announced 2025-10-08

Medical Imaging System Helium Leak Risk Due to Ice Blockage

Siemens MAGNETOM Vida MRI systems may have ice blockage in the magnet venting system, potentially causing helium gas pressure buildup and rupture of the containment system, leading to helium 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, which mandates a minimum score of 4 according to the rubric. The hazard involves potential rupture of a pressurized helium containment system with risk of gas leak into an occupied scanning room.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the MAGNETOM Vida (DE) MRI scanner system (Model 11060815) due to a potential safety hazard in the magnet venting system.

The system may have ice blockage that could form or currently exist within the magnet venting system. During a quench event (when the superconducting magnet loses superconductivity), helium gas is designed to escape through designated venting paths. If ice blocks these paths, the helium gas cannot escape properly, causing pressure to build up inside the helium containment system. This pressure buildup could rupture the helium containment system and cause helium gas to leak into the scanning room.

Approximately 498 units have been distributed worldwide, including throughout the United States and internationally.

The recalled product

Product
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — MRI Scanner
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: 11060815. UDI Numbers: (01)04056869039176(21)176636
  • (01)04056869039176(21)177211
  • (01)04056869039176(21)175728
  • (01)04056869039176(21)175685
  • (01)04056869039176(21)175851
  • (01)04056869039176(21)175768
  • (01)04056869039176(21)177298
  • (01)04056869039176(21)177295
  • (01)04056869039176(21)176756
  • (01)04056869039176(21)175754
  • (01)04056869039176(21)177349
  • (01)04056869039176(21)176757
  • (01)04056869039176(21)177232
  • (01)04056869039176(21)175935
  • (01)04056869039176(21)176967
  • (01)04056869039176(21)175741
  • (01)04056869039176(21)177052
  • (01)04056869039176(21)176060
  • (01)04056869039176(21)176371
  • (01)04056869039176(21)177012

Distribution

Distributed nationwide across the United States.

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