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
- 10849582
- 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
An ice blockage in the magnet venting system can prevent helium gas from escaping during a quench. This can raise pressure inside the helium containment system and may rupture it, allowing helium to leak into the scanning room.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may face urgent downtime and require coordination for replacement or service. Patient throughput and safety planning will be impacted while units are addressed.
Practical Guidance
How to identify if yours is affected
- 1. Confirm model number 10849582 on the device nameplate.
- 2. Cross-check the listed UDIs against your asset records.
- 3. Review recall notification letters from Siemens.
Where to find product info
Check factory nameplate, hospital asset registry, and the FDA recall page referenced in notices.
What timeline to expect
Timeline for service or replacement will be coordinated by Siemens with the purchasing facility. Specific timelines were not disclosed in the notice.
If the manufacturer is unresponsive
- Escalate through hospital risk management or procurement teams.
- Document all communications with Siemens and the FDA, and consider filing a formal complaint if the manufacturer is unresponsive.
How to prevent similar issues
- Maintain an updated asset register with model numbers and UDIs.
- Establish a clear recall notification workflow with the manufacturer.
Documentation advice
Keep a copy of the recall notice, the asset inventory, recall communication logs, and any service or replacement agreements.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US and 60+ countries
- No injuries reported to date
- Recall status: ACTIVE
- Recall notification by letter
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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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