Siemens Medical Solutions USA MAGNETOM Prisma MRI Recalled for Ice Blockage Risk in 39 Units (2025)
Siemens Medical Solutions USA recalled 39 MAGNETOM Prisma MRI systems sold worldwide to healthcare providers. A potential ice blockage in the magnet venting system could prevent helium gas from escaping during a quench, causing pressure to build and potentially rupture the helium containment system. Hospitals and imaging centers using MAGNETOM Prisma should stop using the devices immediately and,,
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
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
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About This Product
MAGNETOM Prisma is a magnetic resonance imaging system used in hospital imaging departments for diagnostic scans. It is part of Siemens' portfolio of advanced MRI platforms.
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.
Verify vendor communications and confirm recall status before any maintenance.
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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