MAGNETOM MRI scanners recalled for potential ice blockage in helium venting system
Certain Siemens MRI scanners have a defect where ice can block the helium cooling system. This could cause pressure buildup, rupture the containment, and release helium gas 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 medical device recall requires a minimum severity score of 4. While no injuries or illnesses have been reported and the hazard remains theoretical, the Class I designation reflects the serious potential consequences of helium containment rupture and environmental release.
Plain-English summary
Siemens Medical Solutions is recalling certain MAGNETOM Verio MRI scanners (Model Number 10276755) due to a potential ice blockage hazard in the magnet venting system.
The issue involves potential ice formation or blockage within the helium venting system. If this occurs, helium gas may be unable to escape through the designed venting paths during a quench event, leading to pressure buildup within the helium containment system. This pressure buildup could rupture the helium containment system, potentially releasing helium into the scanning room.
Approximately 154 units have been distributed worldwide, including across the United States and internationally to over 100 countries. The affected equipment is identified by Model Number 10276755, with specific serial numbers listed in the FDA recall notice.
Facilities operating affected MAGNETOM scanners should contact Siemens Medical Solutions USA, Inc for guidance on inspection, remediation, or replacement options. This is a Class I recall issued by the FDA.
The recalled product
- Product
- MAGNETOM Verio. Model Number: 10276755.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- 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: 10276755. UDI Numbers: N/A. Serial Numbers: 40649
- 40585
- 40781
- 40243
- 40408
- 40628
- 40848
- 40870
- 40783
- 40473
- 40240
- 40497
- 40564
- 40425
- 40778
- 40389
- 40340
- 40523
- 40582
- 40168
Distribution
Distributed nationwide across the United States.
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