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, PREGNANT, PETS
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 Magnet / MRI System
- Model numbers
- Model Number: 11516217. UDI Numbers: (01)04056869299273(21)212018, (01)04056869299273(21)212023, (01)04056869299273(21)212030, (01)04056869299273(21)212032, (01)04056869299273(21)212034, (01)04056869299273(21)212035, (01)04056869299273(21)212038, (01)04056869299273(21)212039 +13 more
- 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 MAGNETOM Skyra Fit BioMatrix MRI system is used for clinical imaging in hospitals and imaging centers. The recall involves magnet venting and helium containment components.
Why This Is Dangerous
Ice blockage in venting can prevent helium gas from escaping during a quench, risking a rupture and helium release into the scanning room.
Industry Context
This recall is not part of a broader industry pattern indicated in the data.
Real-World Impact
Hospitals must pause use of the affected units, coordinate with Siemens for service, and may incur downtime and replacement costs.
Practical Guidance
How to identify if yours is affected
- Confirm model number 11516217
- Check serial numbers for 212018, 212023, 212030
- Verify device data plate and UDI codes
- Cross-check recall notice from FDA/accessdata site
Where to find product info
Serial numbers on device label, patient console, or asset management records
What timeline to expect
Recall processing and remediation timelines vary; plan for service arrangements and possible downtime
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact Siemens regional service office
- Consult FDA recall enforcement page for updates
How to prevent similar issues
- Establish a robust asset-tracking system for MRI units
- Ensure rapid contact with vendor for recalls
Documentation advice
Keep copy of recall notice, incident log, asset records, and service communications
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Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Ice blockage risk in magnet venting
- Quench could cause helium leak
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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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