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
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
- 11689172
- Sold at
- Unknown
- 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 One MRI System is a high-field imaging device used in clinical scanning to produce detailed soft-tissue images for patient diagnosis.
Why This Is Dangerous
Ice blockage in the magnet venting system can trap helium gas. During a quench, this can cause a dangerous pressure rise and potentially rupture the helium containment, allowing a leak to the scanning room.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt or delay MRI imaging. Facilities must coordinate with vendors for a remedy, which could affect patient scheduling and departmental operations.
Practical Guidance
How to identify if yours is affected
- Verify device model 11689172 and serial 238008
- Refer to manufacturer recall notice for instructions
- Do not attempt to operate device until cleared by Siemens or the facility’s biomedical team
- Follow the remedy plan provided by Siemens Medical Solutions USA
Where to find product info
Device label includes model, serial, and UDI. The recall notice and FDA page provide remedy steps.
What timeline to expect
Remedies typically take 4-8 weeks to process in healthcare settings.
If the manufacturer is unresponsive
- Escalate to hospital risk management and biomedical engineering
- Contact FDA recall coordinator if the vendor remains unresponsive
- Maintain patient safety by isolating and decommissioning the device as advised
How to prevent similar issues
- Ensure venting pathways are clear of ice build-up in MRI systems
- Verify vendor recall notifications and keep a current asset inventory
- Limit non-essential use of MRI systems in extreme weather environments
Documentation advice
Document all communications with the manufacturer, recall dates, device identifiers, and replacement or repair actions; keep copies of all records
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Product Details
Model numbers: 11689172 UDI: (01)4068151020472 (21)238008 Serial numbers: 238008 Where sold: Worldwide distribution including US nationwide and numerous other countries When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US
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Safety Guide
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