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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Medical Solutions USA
- Product type
- MRI System
- Model numbers
- Model Number: 10684333. UDI Numbers: (01)04056869006673(21)160021, (01)04056869006673(21)60108, (01)04056869006673(21)160019, (01)04056869006673(21)60091, (01)04056869006673(21)160043, (01)04056869006673(21)60126, (01)04056869006673(21)60047, (01)04056869006673(21)160003 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 28, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
Why This Is Dangerous
The recall cites an ice blockage risk in the magnet venting system. If a quench occurs, helium gas may not escape, causing pressure buildup and potential rupture of the helium containment system. This could result in a helium leak into the scanning room.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience imaging downtime, mandatory temporary suspensions, and costly service actions. Patient safety is the primary concern in ensuring venting systems function correctly.
Practical Guidance
How to identify if yours is affected
- Verify device model number 10684333 on the unit label.
- Review the UDI numbers listed in the recall notice.
- Confirm the device is among those distributed worldwide.
- Refer to the manufacturer recall communications for next steps.
Where to find product info
Model number and UDIs are on the device label. Official recall notices and instructions are issued by Siemens and the FDA page linked in the recall notice.
What timeline to expect
Remediation actions such as service or replacement are coordinated by the manufacturer. Typical timelines range from several weeks to months depending
If the manufacturer is unresponsive
- Escalate to hospital risk management or the manufacturer’s recall desk.
- If the manufacturer is slow to respond, contact your regulatory body or FDA recall office.
How to prevent similar issues
- Establish a clear inventory of MRI systems and verify model numbers during procurement.
- Ensure venting and quench protection systems are up to date per manufacturer guidelines.
- Monitor for recall updates and maintain open lines of communication with the manufacturer.
Documentation advice
Document all correspondence, store recall letters, and maintain device service records and UDIs for audit purposes.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US and multiple countries
- UDI numbers listed in product details
- Hazard involves potential helium leak during a quench
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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