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 Scanner
- Model numbers
- Model Number: 11060815, (01)04056869039176(21)176636, (01)04056869039176(21)177211, (01)04056869039176(21)175728, (01)04056869039176(21)175685, (01)04056869039176(21)177298, (01)04056869039176(21)177295, (01)04056869039176(21)177349 +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
Why This Is Dangerous
Ice blockage in the venting path can prevent helium gas from escaping during a quench. This leads to pressure buildup and potential rupture of the helium containment, risking a helium leak into the scanning room.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
The immediate impact is operational downtime for facilities and potential exposure to a hazardous helium leak risk. Hospitals must suspend use until instructed otherwise, which could affect diagnostic workflows and scheduling.
Practical Guidance
How to identify if yours is affected
- Verify device model is 11060815.
- Review labeling for UDIs listed in the recall documents.
- Cross-check inventory against the recall list in the manufacturer notice.
Where to find product info
Device labeling and hospital procurement records will include the model number and UDI; the recall notice provides official identifiers.
What timeline to expect
4-8 weeks for recall processing, refunds, or replacements as directed by the manufacturer.
If the manufacturer is unresponsive
- File a formal complaint with the hospital's risk management department.
- Contact FDA callback lines or regional regulatory offices for guidance.
- Document all communications with the manufacturer and hospital administration.
How to prevent similar issues
- Implement proactive venting-system inspection protocols for MRI magnets.
- Ensure quench safety procedures are up to date.
- Maintain regular contact with vendor service engineers for firmware and hardware checks.
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Product Details
Model 11060815. 510(k) numbers listed. Worldwide distribution to healthcare facilities. No consumer price data available. UDI numbers listed in recall records.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution to healthcare providers
- UDI numbers listed in recall documents
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Safety Guide
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