Is this recall limited to MAGNETOM Lumina models with Model Number 11344916?

The recall covers 71 units globally. The provided data specifies Model Number 11344916. Verify with recall notice for exact scope.

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

Do not use the device. Follow the manufacturer's recall instructions and contact Siemens Medical Solutions USA or your healthcare provider for guidance.

How will I know if my unit is affected?

Check the model number 11344916 and the UDI numbers listed in the recall notice.

What is a quench in MRI systems?

A quench rapidly releases helium to depressurize the magnet. If venting is blocked, pressure could build and leak.

What are the next steps for refunds or replacements?

Follow the recall instructions. The recall notes notification by letter.

Are there safety risks to patients during scanning?

Yes. If helium leaks into the scanning room, it can create hazardous conditions; stop using immediately.

Will Siemens provide a fix or replacement?

The recall notice instructs to stop use and follow manufacturer instructions for remediation.

How long will remediation take?

Timelines are not specified in the provided data; follow the recall notice for details.

Is there a public-hotline for recall questions?

Refer to the recall notice for contact details from Siemens or healthcare providers.

Who enforces recall actions for medical devices?

The U.S. FDA and international health authorities oversee recalls for medical devices.

HIGHAugust 28, 2025

Siemens MAGNETOM Lumina MRI System Recall Covers 71 Units Worldwide for Ice Blockage Risk

Siemens Medical Solutions USA recalled 71 MAGNETOM Lumina MRI systems worldwide, including US and 50+ countries, due to ice blockage in the magnet venting system that could cause a helium leak during a quench.

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

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

MAGNETOM Lumina is a high-field MRI system used in medical imaging. It is designed for diagnostic scanning in healthcare facilities.

Why This Is Dangerous

Ice blockage in the magnet venting system may prevent helium venting during a quench, raising pressure and risking rupture and helium leakage into the scanning room.

Industry Context

This recall is not specified as part of a broader industry pattern in the provided data.

Real-World Impact

Immediate cessation of use is required to prevent potential helium leaks during MRI procedures; hospitals must follow recall instructions and coordinate with Siemens for remediation.

Practical Guidance

How to identify if yours is affected

Check model number 11344916 against recall notice.
Review UDI numbers listed: 01 04056869230740 21 196591 and others.
Confirm distribution country and unit serials if available.

Where to find product info

Recall notice or Siemens support portal for device identifiers and instructions.

What timeline to expect

Remediation timelines are not specified; follow recall notice for processing and replacements.

If the manufacturer is unresponsive

Escalate to hospital risk management.
Contact regulatory authorities or your local health authority if the manufacturer is unresponsive.

How to prevent similar issues

Establish a routine venting-system inspection for MRI magnets.
Document all recalls and validate units during annual inspections.

Documentation advice

Keep recall letters, device IDs, serials, and correspondence with Siemens for record-keeping.

Product Details

Model Number: 11344916. Distribution: Worldwide. Quantity: 71 units. Recall date: 2025-08-28. Status: ACTIVE.

Reported Incidents

No specific incidents or injuries are listed in the provided data.

Key Facts

71 units recalled
Global distribution in 50+ countries
Ice blockage in magnet venting system
Potential helium leak in scanning room
Recall status: ACTIVE

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

GENERALPREGNANTPETSPREGNANT

Injury Types

POISONINGELECTRICALFALLSUFFOCATIONLACERATION

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMRI Scanner magnet (MAGNETOM Lumina)

Product Details

Brand

Siemens Medical Solutions USA

Related Recalls

Health & Personal Care

HIGH

Siemens ARTIS pheno and ARTIS Icono Imaging Systems Recalled for Dose-Display Anomaly (2026)

Siemens Medical Solutions USA recalled 758 units in the U.S. and 2,077 outside the U.S. of ARTIS pheno and ARTIS Icono imaging systems after a dose-display anomaly could misrepresent high X-ray doses. The devices may still be within regulatory dose limits, but the displayed dose may appear significantly higher. Clinicians should stop using the devices and await manufacturer guidance.

Mar 10, 2026

Siemens Medical Solutions USA

During patient

Health & Personal Care

HIGH

Siemens X-Ray System Recalled Due to Image Processing Errors

Siemens Medical Solutions USA recalled five LUMINOS Q.namix T X-ray systems on December 29, 2025. The recall affects devices that can process images from previous patients due to a software issue. Healthcare providers must stop using these devices immediately.

Dec 29, 2025

Siemens Medical Solutions USA

Ortho images

Health & Personal Care

HIGH

Siemens Recalls Interventional Fluoroscopic X-Ray System Over Imaging Risk

Siemens Medical Solutions USA recalled 40 units of its LUMINOS Q.namix R X-ray system on December 29, 2025. The recall addresses a defect that may result in images being incorrectly processed, potentially showing images from previous patients. Healthcare providers should stop using the device immediately and follow recall instructions.

Dec 29, 2025

Siemens Medical Solutions USA

Ortho images

Health & Personal Care

HIGH

Siemens Medical Recalls CT Software Over FDA Clearance Issues

Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.

Dec 19, 2025

Siemens Medical Solutions USA

To remove

Health & Personal Care

HIGH

Siemens Medical Recalls Software Due to Lack of FDA Clearance

Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.

Dec 19, 2025

Siemens Medical Solutions USA

To remove

Health & Personal Care

HIGH

Siemens Medical Solutions Recalling CT Software Over Clearance Issues

Siemens Medical Solutions USA recalled two units of its NAEOTOM Alpha.Pro software applications on December 19, 2025. The recall affects software used in CT systems that lack FDA 510(k) clearance. Healthcare providers and patients must stop using the software immediately.

Dec 19, 2025

Siemens Medical Solutions USA

To remove

Health & Personal Care

HIGH

Siemens Medical Recalls NAEOTOM Alpha CT Software Over FDA Clearance Issue

Siemens Medical Solutions USA, Inc. recalled 88 units of NAEOTOM Alpha software applications on December 19, 2025. The applications lack FDA 510(k) clearance, posing potential risks to patient safety. Healthcare providers must stop using the software immediately and follow the manufacturer's instructions.

Dec 19, 2025

Siemens Medical Solutions USA

To remove

Health & Personal Care

HIGH

Siemens Recalls LUMINOS Medical Imaging Systems Over Collimation Risk

Siemens Medical Solutions USA recalled LUMINOS Lotus Max and Luminos dRF Max systems on December 5, 2025. The recall affects systems with software version VF11 and involves a potential collimation error. Healthcare providers and patients must stop using the devices immediately.

Dec 5, 2025

Siemens Medical Solutions USA

A potential