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
- Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213043, (01)04056869975221(21)213041, (01)04056869975221(21)213034, (01)04056869975221(21)213028, (01)04056869975221(21)213061, (01)04056869975221(21)213005, (01)04056869975221(21)213056, (01)04056869975221(21)213057 +1 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
MRI systems diagnose medical conditions using strong magnetic fields. The MAGNETOM Cima.X is a high-field MRI system used in hospitals for imaging patients.
Why This Is Dangerous
Ice blockage in the venting path can trap helium. A quench may raise pressure and rupture containment, releasing helium into the scanning room.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
High risk for facilities with the affected units. No injuries reported yet. Hospitals must halt use until advised.
Practical Guidance
How to identify if yours is affected
- Check model number 11647158 and all listed UDIs/serial numbers.
- Review asset records for the nine units distributed worldwide.
- Compare device identifiers to the recall list provided by Siemens and the FDA notice.
Where to find product info
Look for model number, UDI, and serial numbers on the device label and documentation.
What timeline to expect
Recall remedies and timelines will be provided by Siemens to affected facilities. Expect weeks to months for action.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Engage hospital risk management and regulatory channels.
- Escalate to FDA recall contacts if the vendor is unresponsive.
How to prevent similar issues
- Establish a routine recall monitoring process for high-value medical devices.
- Ensure asset tracking with up-to-date serials and UDIs.
Documentation advice
Keep the recall notice, device identifiers, service records, and all correspondence with the manufacturer.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Class I recall
- Ice blockage risk in magnet venting system
- Global distribution across many countries
- No injuries reported
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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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