Siemens Medical Solutions USA BIOGRAPH One MRI System Recalled for Helium Leak Risk (1 Unit, 2025)
Siemens Medical Solutions USA issued an active recall for 1 unit of the BIOGRAPH One MRI System. The recall cites ice blockage in the magnet venting system that could prevent helium from escaping during a quench, risking rupture and helium leakage into the scanning room. Healthcare providers should follow the manufacturer’s recall instructions immediately.
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
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
Check UDI: (01)4068151020472 (21)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
Schedule regular maintenance checks for Cryogen vent 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
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
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