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 Scanner magnet (MAGNETOM Lumina)
- Model numbers
- Model Number: 11344916, UDI: 01 04056869230740 21 196591, (01)04056869230740(21)196655, (01)04056869230740(21)196355, (01)04056869230740(21)196733, (01)04056869230740(21)196553, (01)04056869230740(21)196519, (01)04056869230740(21)196782 +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
MAGNETOM Lumina is a high-field MRI system used in medical imaging. It is designed for diagnostic scanning in healthcare facilities.
Why This Is Dangerous
Ice blockage in the magnet venting system may prevent helium venting during a quench, raising pressure and risking rupture and helium leakage into the scanning room.
Industry Context
This recall is not specified as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate cessation of use is required to prevent potential helium leaks during MRI procedures; hospitals must follow recall instructions and coordinate with Siemens for remediation.
Practical Guidance
How to identify if yours is affected
- Check model number 11344916 against recall notice.
- Review UDI numbers listed: 01 04056869230740 21 196591 and others.
- Confirm distribution country and unit serials if available.
Where to find product info
Recall notice or Siemens support portal for device identifiers and instructions.
What timeline to expect
Remediation timelines are not specified; follow recall notice for processing and replacements.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Contact regulatory authorities or your local health authority if the manufacturer is unresponsive.
How to prevent similar issues
- Establish a routine venting-system inspection for MRI magnets.
- Document all recalls and validate units during annual inspections.
Documentation advice
Keep recall letters, device IDs, serials, and correspondence with Siemens for record-keeping.
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Product Details
Model Number: 11344916. Distribution: Worldwide. Quantity: 71 units. Recall date: 2025-08-28. Status: ACTIVE.
Reported Incidents
No specific incidents or injuries are listed in the provided data.
Key Facts
- Global distribution in 50+ countries
- Ice blockage in magnet venting system
- Potential helium leak in scanning room
- Recall status: ACTIVE
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Safety Guide
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