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 Scanner
- Model numbers
- Model Number: 10849580. UDI Numbers: (01)04056869006710(21)170068, (01)04056869006710(21)70022, (01)04056869006710(21)170018, (01)04056869006710(21)170039, (01)04056869006710(21)170023, (01)04056869006710(21)170030, (01)04056869006710(21)170004, (01)04056869006710(21)170077 +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
Ice can block magnet vent pathways. A quench then traps helium gas, risking rupture of containment and a helium leak into the scanning area.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals with the affected units must stop use and follow recall directions. The impact is operational disruption and potential safety risk to staff and patients.
Practical Guidance
How to identify if yours is affected
- Identify model number 10849580.
- Check listed UDIs to confirm if the device is affected.
- Review the recall notice for any serial or lot identifiers.
What timeline to expect
Remediation timelines will be provided by Siemens and regulatory authorities; specifics will depend on institutional capacity.
If the manufacturer is unresponsive
- Document all communications.
- Escalate to regulatory authorities and hospital risk management.
- File a recall-related complaint with the FDA if needed.
How to prevent similar issues
- Require manufacturers to provide clear recall procedures before purchase.
- Confirm service and recall handling as part of procurement contracts.
- Maintain up-to-date inventory and recall readiness plans.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 30 units recalled worldwide
- UDIs include 20+ identifiers
- Hazard involves potential helium leak from ice blockage
- Recall status: ACTIVE
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.