HIGH

Siemens Medical Recalls MRI Machine Over Helium Leak Risk

Siemens Medical Solutions USA recalled 182 MRI machines on August 28, 2025, due to a risk of helium leaks. An ice blockage in the magnet venting system could cause pressure build-up, leading to a potential rupture. Users must stop using the device and follow recall instructions immediately.

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 recall involves MAGNETOM Skyra (DE), Model Number: 10432915. The devices were distributed worldwide, including the US and 87 other countries. No price information is provided.

The Hazard

An ice blockage may form in the magnet venting system. This blockage could prevent helium gas from escaping, leading to a dangerous pressure build-up.

Reported Incidents

No injuries or deaths have been reported related to this issue. The recall is precautionary due to potential safety risks.

What to Do

Stop using the MRI machines immediately. Contact Siemens Medical Solutions USA for instructions and follow the notification letter provided.

Contact Information

For more information, contact Siemens Medical Solutions USA at the number provided in the recall letter or visit their website.

Key Facts

  • 182 units recalled
  • Potential helium leak risk
  • Stop using devices immediately
  • Worldwide distribution
  • Class I recall

Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model Number: 10432915. UDI Numbers: (01)04056869006703(21)145760
(01)04056869006703(21)45549
(01)04056869006703(21)146110
(01)04056869006703(21)146093
(01)04056869006703(21)146082
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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