HIGH

Siemens MRI System Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled 69 units of the MAGNETOM Verio MRI system on August 28, 2025. Ice blockage in the magnet venting system could lead to a helium leak, posing serious risks. Healthcare providers must stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
August 28, 2025
Hazard Level
HIGH
Brand
Siemens Medical Solutions USA
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter

Product Details

The recalled product is the MAGNETOM Verio MRI System, Model Number 10276755. It has been distributed worldwide, including the US and 75 other countries. The quantity recalled is 69 units.

The Hazard

Ice blockages may form in the magnet venting system of the MRI system. This could prevent helium gas from escaping during a quench, leading to dangerous pressure build-up and potential rupture of the helium containment system.

Reported Incidents

No specific incidents or injuries have been reported as of the recall date. The potential for helium leaks poses a high risk to users in the scanning room.

What to Do

Stop using the MAGNETOM Verio MRI system immediately. Contact Siemens Medical Solutions USA or your healthcare provider for further instructions on the recall.

Contact Information

For more information, call Siemens Medical Solutions USA or visit their website. Additional resources can be found at the FDA recall notice.

Key Facts

  • 69 units recalled
  • Class I recall
  • Risk of helium leak
  • Stop using the device immediately
  • Contact manufacturer for instructions

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMagnetic Resonance Imaging (MRI) System
Sold At
Multiple Retailers

Product Details

Model Numbers
Model Number: 10276755. UDI Numbers: N/A. Serial Numbers: 40649
40243
40408
40628
40848
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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