HIGH

Siemens MRI System Recalled Over Potential Helium Leak Risk

Siemens Medical Solutions USA recalled 30 MRI systems on August 28, 2025 due to a risk of helium leaks. The recall affects the MAGNETOM Verio Dot model number 10684333. The potential ice blockage in the venting system could lead to a pressure build-up and rupture.

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 recall involves the MAGNETOM Verio Dot MRI system, model number 10684333. It was distributed worldwide, including the US and multiple countries. The systems were sold at various medical equipment retailers.

The Hazard

An ice blockage may form within the magnet venting system. If a quench occurs, helium gas may not escape, causing pressure build-up and a risk of rupture.

Reported Incidents

No injuries or incidents have been reported at this time. The recall is classified as Class I due to the potential for serious hazards.

What to Do

Stop using the MRI system immediately. Follow the instructions provided by Siemens Medical Solutions USA for further action.

Contact Information

For more information, contact Siemens Medical Solutions USA, Inc. or refer to the recall notification letter.

Key Facts

  • 30 MRI systems affected
  • Stop using immediately
  • Potential helium leak risk
  • Worldwide distribution
  • No injuries reported

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model Number: 10684333. UDI Numbers: (01)04056869006673(21)160021
(01)04056869006673(21)60108
(01)04056869006673(21)160019
(01)04056869006673(21)60091
(01)04056869006673(21)160043
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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