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Siemens Medical Solutions USA, Inc recalls SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross
Recalled August 21, 2019 · FDA recall Z-2271-2019 · Siemens Medical Solutions USA
Hazard
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. · FDA Class II
Units
N/A
Sold at
US Nationwide distribution.
Description
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Product
SOMATOM Drive, Model Number 10431700 - 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 as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →