Siemens MAGNETOM Prisma MRI Devices Recalled for Quench Venting Port Issue
Siemens is recalling 17 MAGNETOM Prisma MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a risk-of-harm product (MRI quench system) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 17 MAGNETOM Prisma magnetic resonance diagnostic devices (Model #10849582). The recall is due to a potential open port in the quench venting system that may occur when using the optional horizontal outlet on the quench line assembly.
The affected devices are distributed across 38 states and the District of Columbia. Specific serial numbers for the 17 units are listed in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — MRI Scanner
- Hazard
- Affected units
- 17
Distribution
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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