Siemens CT Systems Recalled for Software Issues Causing Scan Aborts
Siemens is recalling SOMATOM Definition Edge CT systems due to four safety-related software issues in syngo.CT version VB10A that may result in 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.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling SOMATOM Definition Edge computed tomography (CT) systems, Model Number 10590000. The recall is due to four potential safety-related software issues affecting systems that utilize syngo.CT software version VB10A. These issues may result in a scan abort.
The affected units were distributed nationwide in the United States. The recall covers specific serial numbers, including 83904, 83931, 83834, and others listed in the agency documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the software issues and potential scan aborts.
The recalled product
- Product
- SOMATOM Definition Edge, Model Number 10590000 - 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 physi
- 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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