Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Siemens
- 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
- Product type
- MRI Scanner
- Model numbers
- 10433372, UDI (01)04056869006741(21)151032, UDI (01)04056869006741(21)151057, UDI (01)04056869006741(21)510535, UDI (01)04056869006741(21)151034, UDI (01)04056869006741(21)51003, UDI (01)04056869006741(21)151021, UDI (01)04056869006741(21)51055 +13 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
About This Product
The Biograph mMR is a PET-MRI system used by hospitals to perform combined metabolic and anatomic imaging. It plays a critical role in oncology, neurology, and cardiology diagnostics.
Why This Is Dangerous
Ice blockage in the magnet venting system may prevent helium gas from escaping during a quench. This can raise pressure and rupture the helium containment, potentially releasing helium into the scanning room.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals must halt use of affected units. Depending on remediation timing, patient imaging schedules could be disrupted and safety precautions must be strictly followed.
Practical Guidance
How to identify if yours is affected
- Verify device model number is 10433372.
- Check the UDI list for matching identifiers.
- Confirm the unit count in your facility equals 23 globally affected units.
Where to find product info
Model numbers and UDIs are on the device label and in the recall documentation provided to facilities.
What timeline to expect
Remediation timelines vary by facility; typical service or replacement processing may take weeks.
If the manufacturer is unresponsive
- Document all contact attempts with Siemens.
- Escalate to hospital compliance or safety offices.
- File a notice with the FDA if necessary.
How to prevent similar issues
- Maintain current contact records for manufacturers.
- Monitor for further recall communications from FDA/Siemens.
Documentation advice
Keep the recall notification, serial numbers, UDIs, photos of the device label, and all correspondence with Siemens for records.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 23 units recalled worldwide
- Model 10433372 with multiple UDIs
- Ice blockage in magnet venting system
- Quench could cause helium leak into scanning room
- Stop use immediately; follow manufacturer instructions
- Recall notification by letter
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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