What is being recalled?

The MAGNETOM Verio Dot Upgrade MRI System, Model Number 10684334, with 19 UDIs, is recalled due to an ice blockage in the magnet venting system that could cause a helium leak during a quench.

How many units are affected?

46 units are affected by this recall worldwide, including US hospitals and many other countries.

What should I do if I own or operate one of these MRI systems?

Stop using the device immediately and follow the manufacturer's recall instructions. Contact Siemens Medical Solutions USA or your healthcare provider for guidance.

Are there any reported injuries or incidents?

No injuries or incidents have been reported to date.

How will the recall be resolved?

Siemens will provide instructions for service actions or replacements as directed to affected facilities.

How can I identify if my device is affected?

Check the model number 10684334 and compare the listed UDIs to the device's label or documentation.

Where can I find the device's model and UDI information?

UDI numbers and model information are on the device nameplate and in the recall notice from the FDA.

Who should I contact for recall support?

Contact Siemens Medical Solutions USA for recall guidance or your hospital's biomedical engineering team. FDA pages linked in the recall notice also provide official information.

What is a quench in an MRI system?

A quench is a rapid loss of superconductivity in the magnet, which vents helium to the room. The recall concerns venting inefficiency due to ice blockage.

Will I receive a refund or replacement?

Refunds are not applicable to hospital MRI equipment recalls. Replacement or service actions will be coordinated by Siemens and the facility.

HIGHAugust 28, 2025

Siemens MAGNETOM Verio Dot Upgrade MRI Recalled Over Ice Blockage Risk (46 Units) 2025

Siemens Medical Solutions USA recalled 46 MAGNETOM Verio Dot Upgrade MRI systems sold to hospitals worldwide after an ice blockage could prevent venting during a quench. The blockage could cause pressure to build in the helium containment system, potentially rupturing it and releasing helium into the scanning room. Hospitals and providers should stop using the device immediately and follow Siemens

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

The MAGNETOM Verio Dot Upgrade is a magnetic resonance imaging system used by hospitals for diagnostic imaging and treatment planning.

Why This Is Dangerous

Ice blockage in the magnet venting system can prevent helium from escaping during a quench. The resulting pressure buildup could rupture the helium containment and cause a helium leak into the scanning room.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals may experience imaging downtime and need to coordinate with Siemens for service actions. The recall presents potential safety risks during device operation and requires immediate stop-use actions.

Practical Guidance

How to identify if yours is affected

Verify model number on the device label is 10684334.
Review the list of UDIs provided in the recall notice and compare to your device's UDI on the nameplate.
If affected, halt use and contact Siemens Medical Solutions USA for instructions.

Where to find product info

Device nameplate, hospital procurement records, and the FDA recall page linked in the notice.

What timeline to expect

Service actions and replacements will be scheduled by Siemens with the hospital. No general refund window is published.

If the manufacturer is unresponsive

Escalate with hospital administration or biomedical engineering.
File a complaint with the FDA if the facility experiences delays or safety concerns.

How to prevent similar issues

For future MRI equipment purchases, verify venting and quench safety features with the OEM.
Maintain updated service agreements with manufacturers and monitor recall notices from FDA and OEMs.

Documentation advice

Keep a copy of the recall notice, record all communications with Siemens, and document any actions taken with the device.

Product Details

Model numbers and identifiers for this recall include Model Number 10684334 and multiple UDIs. The devices were distributed Worldwide, including US Nationwide and numerous countries listed by the FDA recall notice. Sold to hospitals and healthcare facilities. No price information available.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

46 units recalled
Model Number 10684334
UDIs include 19 listed identifiers
Global distribution to US hospitals and country list

View Original Recall on FDA - Medical Devices

Browse More Recalls

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Imaging Equipment

Product TypeMRI System

Product Details

Dec 5, 2025

Siemens Medical Solutions USA

A potential