What is the risk if my MRI shows the recall notice?

The recall concerns potential ice blockage in the magnet venting system that could cause a helium leak during a quench. Stop using the device and contact the manufacturer for instructions.

How many units are affected?

The recall indicates 1 unit worldwide with a Class I risk level.

Where can I find the model number and serial number?

Model number is 10655588. Serial number is 56069. UDI is (01)04056869006796(21)56069.

What should I do immediately if I own this device?

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

Is financial compensation available?

Remedies are determined by the manufacturer and may include repair, replacement, or refund per recall instructions.

Where can I find official recall documents?

Refer to the FDA enforcement page linked in the recall notice and the related enforcement report Z-2663-2025.

Will the device be repaired or replaced?

The recall notes follow manufacturer instructions. Details on repair or replacement will be provided by Siemens.

What is quenching in MRI devices?

Quenching rapidly vents helium to stop the superconducting magnet. A vent blockage could prevent venting and cause pressure buildup.

Should patients be in the scanning room during recall?

No. The device should not be used while under recall.

How will I be notified?

Notification method is by letter as stated in the recall.

HIGHAugust 28, 2025

Siemens MAGNETOM Spectra MRI Recalled, Ice Blockage in Venting May Cause Helium Leak (2025)

Siemens Medical Solutions USA recalls MAGNETOM Spectra MRI with Model Number 10655588 after possible ice blockage in the magnet venting system could cause a helium leak during a quench. The recall covers worldwide distribution including the United States. Patients should stop using the device and follow manufacturer instructions for recall procedures.

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

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About This Product

MAGNETOM Spectra is a magnetic resonance imaging system used to produce detailed body images for diagnostics. MRI systems are critical in hospitals and clinics for a wide range of imaging needs.

Why This Is Dangerous

Ice blockage in the magnet venting system can prevent helium from escaping during a quench. Pressure buildup may rupture the containment system and release helium into the scanning room.

Industry Context

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

Real-World Impact

A single unit recall with high risk suggests urgent action for any affected facility. Replacement or repair is determined by Siemens and may affect ongoing imaging services.

Practical Guidance

How to identify if yours is affected

Check model number 10655588 and serial number 56069.
Review UDI 01-04056869006796-21-56069 on device label.
Confirm if device is part of the worldwide distribution in the recall.

Where to find product info

Model, serial numbers, and UDI are typically on the device nameplate and in the EHR system’s asset record.

What timeline to expect

Refund or repair timelines will be provided by Siemens after notification; typical hospital recall operations can span weeks to months.

If the manufacturer is unresponsive

Escalate to hospital risk management.
Contact Siemens Medical Solutions USA customer support for official guidance.
File an FDA safety report if you believe there is imminent danger.

How to prevent similar issues

Verify venting system integrity during routine maintenance.
Maintain updated recall communications with the manufacturer.
Document all recall communications and device status changes.

Documentation advice

Keep a copy of the recall notice, all correspondence with Siemens, and any service records related to the device.

Product Details

Product: MAGNETOM Spectra (CN). Model Number: 10655588. Distribution: Worldwide. Recall date: 2025-08-28. Status: Active. Quantity: 1 unit.

Reported Incidents

No specific injuries or incidents are described in the provided data. The recall is classified as Class I with a high hazard level due to potential catastrophic failure.

Key Facts

Model: 10655588
Classification: Class I recall
Hazard: Ice blockage in magnet venting system leading to helium leak during quench
Global distribution including US and 70+ countries
Status: Active as of 2025-10-08

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

9/ 10

Affected Groups

GENERAL

Injury Types

POISONINGELECTRICALFALLSUFFOCATIONOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMRI Magnet System

Product Details

Dec 5, 2025

Siemens Medical Solutions USA

A potential