The Recall Desk
SevereFDA (Devices)·Z-2666-2025·Announced 2025-10-08

MAGNETOM Verio Dot MRI Helium Leak Risk Due to Venting Defect

Siemens is recalling 78 MAGNETOM Verio Dot Upgrade MRI systems due to a potential ice blockage in the helium venting system that could cause pressurization and rupture during a quench event, potentially releasing helium 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 medical device Class I recall. While no illnesses or injuries have been reported, the potential for helium containment system rupture and cryogenic gas leak into the scanning room represents a serious hazard that meets the Class I threshold.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 78 units of the MAGNETOM Verio Dot Upgrade (Model Number 10684334) due to a potential defect in the magnet venting system.

A potential ice blockage may form or currently exist within the magnet venting system. In the event of a helium quench, the blockage could prevent helium gas from escaping through its designed venting pathways, causing pressure to build up within the helium containment system. This pressure buildup could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

The affected units have been distributed worldwide, including throughout the United States and internationally. Facilities with affected units should contact Siemens Medical Solutions USA, Inc. immediately.

The recalled product

Product
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device
Hazard
  • ice-blockage
  • pressure-buildup
  • helium-leak

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: 10684334. UDI Numbers: (01)04056869006680(21)162012
  • (01)04056869006680(21)162055
  • (01)04056869006680(21)162039
  • (01)04056869006680(21)162002
  • (01)04056869006680(21)162014
  • (01)04056869006680(21)162069
  • (01)04056869006680(21)162083
  • (01)04056869006680(21)162075
  • (01)04056869006680(21)162028
  • (01)04056869006680(21)162060
  • (01)04056869006680(21)162035
  • (01)04056869006680(21)162038
  • (01)04056869006680(21)162016
  • (01)04056869006680(21)62040
  • (01)04056869006680(21)162036
  • (01)04056869006680(21)162079
  • (01)04056869006680(21)162054
  • (01)04056869006680(21)162088
  • (01)04056869006680(21)162071
  • (01)04056869006680(21)162078

Distribution

Distributed nationwide across the United States.

Related recalls

Same category