HIGH

Siemens MRI Device Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled 27 units of its MAGNETOM Vida Fit MRI system on August 28, 2025. The recall addresses a risk of ice blockage that can cause helium gas pressure build-up. This defect may lead to a helium leak in the scanning room, posing a safety hazard.

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

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Product Details

The affected product is the MAGNETOM Vida Fit MRI system, Model Number 11410481. It has been distributed worldwide, including the US, since its release.

The Hazard

The MRI system may experience ice blockage in its venting system. In a quench event, helium gas could be trapped, resulting in dangerous pressure build-up and potential rupture.

Reported Incidents

There are no reported injuries or incidents associated with this recall. However, the potential for a serious helium leak exists.

What to Do

Stop using the device immediately. Healthcare providers should contact Siemens Medical Solutions USA for further instructions.

Contact Information

For more information, contact Siemens Medical Solutions USA at their official website or through the recall notification letter.

Key Facts

  • 27 units recalled
  • Risk of helium leak
  • Stop using immediately
  • Contact Siemens for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 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: 11410481. UDI Numbers: (01)04056869245188(21)202129
(01)04056869245188(21)202025
(01)04056869245188(21)202139
(01)04056869245188(21)202016
(01)04056869245188(21)202051
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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