Siemens Recalls SOMATOM Scope CT Systems for Power Cutout Risk
Siemens is recalling 13 SOMATOM Scope CT systems to replace a component that could cause a power cutout during use.
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 medical device with a potential defect that could lead to a power cutout during use, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 13 SOMATOM Scope Computed tomography x-ray systems. The recall addresses a potential defect in the Residual Current Monitor (RCM) located in the Line Connection Box (LCB).
The defect could lead to a power cutout during the use of the SOMATOM Scope, Scope Power, and Perspective systems. To resolve this issue, Siemens is providing a new installation of the RCM in the LCB.
The affected systems were distributed to facilities in Illinois, Georgia, South Carolina, South Dakota, Oklahoma, New York, Michigan, Indiana, Maryland, and Arkansas. Specific serial numbers for the 13 affected units are listed in the official recall documentation.
The recalled product
- Product
- SOMATOM Scope, Computed tomography x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 13
Distribution
Part of a larger recall action
This product is one of 3 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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