Siemens MAGNETOM Skyra MRI Devices Recalled for Quench Venting System Defect
Siemens is recalling 44 MAGNETOM Skyra MRI devices due to a potential open port in the quench venting system when using an optional horizontal outlet.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a structural defect in a high-risk medical device (MRI) that could lead to harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 44 MAGNETOM Skyra magnetic resonance diagnostic devices (Model # 10432915). 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 were distributed to facilities in 40 states and the District of Columbia. Specific serial numbers for the recalled units are listed in the agency's structured product information.
The source text does not specify the required corrective action or provide instructions for consumers or facility operators on how to proceed. No injuries or illnesses are reported in the provided text.
The recalled product
- Product
- MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 44
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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