Siemens SOMATOM Confidence CT Systems Recalled for Software Safety Issues
Siemens Medical Solutions is recalling SOMATOM Confidence CT systems due to four software issues that may cause scan aborts.
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 for safety-related issues (scan aborts) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling SOMATOM Confidence computed tomography (CT) systems, Model Number 10590100. The recall involves specific serial numbers distributed nationwide in the United States.
The recall is issued due to four potential safety-related software issues in systems utilizing syngo.CT software version VB10A. These issues may result in a scan abort. The source text does not report any injuries, illnesses, or deaths associated with this recall.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issues. The source text does not provide specific consumer action steps beyond the recall notification.
The recalled product
- Product
- SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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