HIGH

Siemens MAGNETOM Verio Dot MRI Recall 30 Units Over Ice Blockage Risk (2025)

Siemens Medical Solutions USA recalled 30 MAGNETOM Verio Dot MRI systems sold worldwide through hospitals and medical facilities. The ice blockage in the magnet venting system could trap helium during a quench, causing pressure buildup and a potential helium leak into the scanning room. Facilities should stop using the devices immediately and follow the manufacturer’s 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

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About This Product

The MAGNETOM Verio Dot is a magnetic resonance imaging system used in clinical settings to produce high-resolution diagnostic images. Hospitals and imaging centers rely on these systems for patient care and scheduling.

Why This Is Dangerous

The recall cites an ice blockage risk in the magnet venting system. If a quench occurs, helium gas may not escape, causing pressure buildup and potential rupture of the helium containment system. This could result in a helium leak into the scanning room.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals may experience imaging downtime, mandatory temporary suspensions, and costly service actions. Patient safety is the primary concern in ensuring venting systems function correctly.

Practical Guidance

How to identify if yours is affected

  1. Verify device model number 10684333 on the unit label.
  2. Review the UDI numbers listed in the recall notice.
  3. Confirm the device is among those distributed worldwide.
  4. Refer to the manufacturer recall communications for next steps.

Where to find product info

Model number and UDIs are on the device label. Official recall notices and instructions are issued by Siemens and the FDA page linked in the recall notice.

What timeline to expect

Remediation actions such as service or replacement are coordinated by the manufacturer. Typical timelines range from several weeks to months depending

If the manufacturer is unresponsive

  • Escalate to hospital risk management or the manufacturer’s recall desk.
  • If the manufacturer is slow to respond, contact your regulatory body or FDA recall office.

How to prevent similar issues

  • Establish a clear inventory of MRI systems and verify model numbers during procurement.
  • Ensure venting and quench protection systems are up to date per manufacturer guidelines.
  • Monitor for recall updates and maintain open lines of communication with the manufacturer.

Documentation advice

Document all correspondence, store recall letters, and maintain device service records and UDIs for audit purposes.

Product Details

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 (01)04056869006673(21)60126 (01)04056869006673(21)60047 (01)04056869006673(21)160003 (01)04056869006673(21)160042 (01)04056869006673(21)160024 (01)04056869006673(21)160035 (01)04056869006673(21)60099 (01)04056869006673(21)160007 (01)04056869006673(21)160006 (01)04056869006673(21)160009 (01)04056869006673(21)160033 (01)04056869006673(21)160027 (01)04056869006673(21)160012 (01)04056869006673(21)160016 (01)04056869006673

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 30 units recalled
  • Global distribution including US and multiple countries
  • Model Number 10684333
  • UDI numbers listed in product details
  • Hazard involves potential helium leak during a quench

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

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
Recall Status
ACTIVE

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