What is the recall number and which products are affected?

The recall covers 18 MAGNETOM Skyra Fit BioMatrix MRI systems with Model Number 11516217. Serial numbers include 212018, 212023, and 212030 among others.

What caused the recall?

Ice blockage in the magnet venting system may trap helium gas during a quench, causing pressure to build and potentially rupture the helium containment and leak into the scanning room.

What should facilities do now?

Stop using the affected MRI systems and follow the manufacturer's recall instructions. Contact Siemens Medical Solutions USA or a healthcare provider for guidance.

Is there a safety risk to patients or staff?

Yes. A helium leak could occur if venting fails during a quench, creating potential exposure to helium and a sudden change in scanner containment conditions.

How will I get a replacement or refund?

The recall provides manufacturer-directed remedies. Contact Siemens or your healthcare facility's administrator for the exact steps and timelines.

Where can I find the affected serial numbers or model numbers?

Affected units list includes Model 11516217 and serials such as 212018, 212023, and 212030. Check hospital asset records and the device’s data plate.

What if the device shows no symptoms?

Do not use the device until instructions are followed. Manufacturer guidance supersedes symptoms alone.

What is the expected timeline for recalls and replacements?

The recall timeline is determined by Siemens and the healthcare provider network. Typical recall processing can run weeks to months depending on service arrangements.

Can I continue to use the device if it seems fine?

No. Follow the recall instruction to stop use immediately.

HIGHAugust 28, 2025

Siemens MRI Recall: 18 MAGNETOM Skyra Fit BioMatrix Systems Recalled Over Helium Vent Blockage Risk

Q: Who should be contacted for recall actions?

Contact Siemens Medical Solutions USA, Inc. or your healthcare provider for instructions.

Siemens Medical Solutions USA recalls 18 MAGNETOM Skyra Fit BioMatrix MRI systems worldwide due to ice blockage in the magnet venting system that could trap helium gas during a quench. The risk is a ruptured helium containment and a potential helium leak into the scanning room. Hospitals and clinicians should stop using the affected devices and await manufacturer 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: Unknown
Geographic Scope: 1 states
At-Risk Groups: GENERAL, PREGNANT, PETS

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 Skyra Fit BioMatrix MRI system is used for clinical imaging in hospitals and imaging centers. The recall involves magnet venting and helium containment components.

Why This Is Dangerous

Ice blockage in venting can prevent helium gas from escaping during a quench, risking a rupture and helium release into the scanning room.

Industry Context

This recall is not part of a broader industry pattern indicated in the data.

Real-World Impact

Hospitals must pause use of the affected units, coordinate with Siemens for service, and may incur downtime and replacement costs.

Practical Guidance

How to identify if yours is affected

Confirm model number 11516217
Check serial numbers for 212018, 212023, 212030
Verify device data plate and UDI codes
Cross-check recall notice from FDA/accessdata site

Where to find product info

Serial numbers on device label, patient console, or asset management records

What timeline to expect

Recall processing and remediation timelines vary; plan for service arrangements and possible downtime

If the manufacturer is unresponsive

Escalate to hospital risk management
Contact Siemens regional service office
Consult FDA recall enforcement page for updates

How to prevent similar issues

Establish a robust asset-tracking system for MRI units
Review venting system maintenance schedules
Ensure rapid contact with vendor for recalls

Documentation advice

Keep copy of recall notice, incident log, asset records, and service communications

Product Details

Model Number: 11516217. Serial numbers include 212018, 212023, 212030. UDI numbers: (01)04056869299273(21)212018, (01)04056869299273(21)212023, (01)04056869299273(21)212030. Distribution: Worldwide. Status: ACTIVE recall as of 2025-10-08. Quantity: 18 units.

Reported Incidents

No injuries or incidents have been reported in the provided data.

Key Facts

18 units recalled
Model 11516217
Global distribution
Ice blockage risk in magnet venting
Quench could cause helium leak

View Original Recall on FDA - Medical Devices

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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

GENERALPREGNANTPETS

Injury Types

ELECTRICALPOISONINGFALL

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMRI Magnet / MRI System

Product Details

Dec 5, 2025

Siemens Medical Solutions USA

A potential