Siemens SOMATOM Definition AS CT Systems Recalled for Software Issues
Siemens Medical Solutions USA is recalling SOMATOM Definition AS CT systems due to four safety-related software issues in syngo.CT version VB10A 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 is classified as FDA Class II, and the hazard involves a risk of harm (scan abort) where injury has not yet 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 SOMATOM Definition AS computed tomography (CT) systems, Model Number 8098027. These systems are intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data, serving as an aid in diagnosis, treatment preparation, and radiation therapy planning.
The recall is due to four potential safety-related software issues impacting systems utilizing syngo.CT software version VB10A. These issues may result in a scan abort. The affected units were distributed nationwide in the United States.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issues. The specific serial numbers affected are listed in the official recall notice.
The recalled product
- Product
- SOMATOM Definition AS, Model Number 8098027 - 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 physicia
- 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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