Siemens SOMATOM Scope Power CT System Recalled for Power Cutout Risk
Siemens is recalling SOMATOM Scope Power CT systems to replace a monitor that could cause power cutouts during use.
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: The recall involves a medical device with a potential defect that could lead to a power cutout during use. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Scope Power, a computed tomography x-ray system, to address a potential defect in the Residual Current Monitor (RCM) located in the Line Connection Box (LCB). This defect could lead to a power cutout during the use of the SOMATOM Scope, Scope Power, and Perspective systems.
The affected units are distributed to facilities in Illinois, Georgia, South Carolina, South Dakota, Oklahoma, New York, Michigan, Indiana, Maryland, and Arkansas. The recall involves specific model and serial numbers, including Model # 10967888 and serial numbers such as 59376, 91766, and 91767.
Siemens is providing a new installation of the Residual Current Monitor in the Line Connection Box to resolve the issue. Healthcare facilities should contact Siemens to schedule the replacement of the defective component.
The recalled product
- Product
- SOMATOM Scope Power, Computed tomography x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
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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