HIGH

Siemens MAGNETOM Vida MRI Recall 237 Units Worldwide Over Ice Blockage Risk (2025)

Siemens Medical Solutions USA recalled 237 MAGNETOM Vida MRI scanners sold worldwide to healthcare providers. The recall cites ice forming in the magnet venting system. A quench could lead to a helium leak into the scanning room. Hospitals must stop using the 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

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 Vida MRI systems are high-field clinical scanners used in hospitals for diagnostic imaging. They are complex, high-value devices requiring professional maintenance and calibration.

Why This Is Dangerous

Ice blockage in the venting path can prevent helium gas from escaping during a quench. This leads to pressure buildup and potential rupture of the helium containment, risking a helium leak into the scanning room.

Industry Context

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

Real-World Impact

The immediate impact is operational downtime for facilities and potential exposure to a hazardous helium leak risk. Hospitals must suspend use until instructed otherwise, which could affect diagnostic workflows and scheduling.

Practical Guidance

How to identify if yours is affected

  1. Verify device model is 11060815.
  2. Review labeling for UDIs listed in the recall documents.
  3. Cross-check inventory against the recall list in the manufacturer notice.

Where to find product info

Device labeling and hospital procurement records will include the model number and UDI; the recall notice provides official identifiers.

What timeline to expect

4-8 weeks for recall processing, refunds, or replacements as directed by the manufacturer.

If the manufacturer is unresponsive

  • File a formal complaint with the hospital's risk management department.
  • Contact FDA callback lines or regional regulatory offices for guidance.
  • Document all communications with the manufacturer and hospital administration.

How to prevent similar issues

  • Implement proactive venting-system inspection protocols for MRI magnets.
  • Ensure quench safety procedures are up to date.
  • Maintain regular contact with vendor service engineers for firmware and hardware checks.

Documentation advice

Keep the recall notice, correspondence with Siemens, maintenance logs, and any downtime records as part of risk management files.

Product Details

Model 11060815. 510(k) numbers listed. Worldwide distribution to healthcare facilities. No consumer price data available. UDI numbers listed in recall records.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 237 units recalled
  • Model 11060815
  • 510(k) numbers: K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K…
  • Worldwide distribution to healthcare providers
  • UDI numbers listed in recall documents
  • Germany origin

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 Details

Model Numbers
Model Number: 11060815
(01)04056869039176(21)176636
(01)04056869039176(21)177211
(01)04056869039176(21)175728
(01)04056869039176(21)175685
+16 more
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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.

Siemens Medical Solutions USA
During patient
Read more
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.

Siemens Medical Solutions USA
Ortho images
Read more
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.

Siemens Medical Solutions USA
Ortho images
Read more
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.

Siemens Medical Solutions USA
To remove
Read more
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.

Siemens Medical Solutions USA
To remove
Read more
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.

Siemens Medical Solutions USA
To remove
Read more
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.

Siemens Medical Solutions USA
To remove
Read more
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.

Siemens Medical Solutions USA
A potential
Read more