HIGH

Siemens Medical Recalls MAGNETOM Verio Dot Over Helium Leak Risk

Siemens Medical Solutions USA recalled 46 MAGNETOM Verio Dot systems on August 28, 2025. The recall stems from a risk of ice blockage in the magnet venting system. This could lead to a helium leak, posing serious safety hazards.

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 Upgrade, Model Number: 10684334, with multiple UDI numbers. These systems were distributed globally, including the United States and many other countries.

The Hazard

A potential ice blockage may form within the magnet venting system. In the event of a quench, helium gas may not escape properly, leading to a dangerous pressure build-up.

Reported Incidents

No specific injuries or incidents have been reported related to this recall. However, the hazard classification is categorized as Class I, indicating a high risk.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Siemens Medical Solutions or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA recall page or contact Siemens Medical Solutions USA, Inc. at their customer service line.

Key Facts

  • Recall date: August 28, 2025
  • Quantity: 46 units recalled
  • Distributed worldwide
  • Potential helium leak hazard
  • Class I recall warning

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Safety Assessment

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

Product Classification

Product TypeMagnetic Resonance Imaging System
Sold At
Multiple Retailers

Product Details

Model Numbers
Model Number: 10684334. UDI Numbers: (01)04056869006680(21)162012
(01)04056869006680(21)162055
(01)04056869006680(21)162039
(01)04056869006680(21)162002
(01)04056869006680(21)162014
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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