SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed t ...



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 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).
Components:
Units Affected:    0
Recall Date:    Jul 3, 2019
Mfg:
Siemens Medical Solutions USA, Inc
Mfg Country:
United States
Recall ID:    83377
Product ID:    174998
Enforcement Date:    Aug 21, 2019
Last Published:    Aug 14, 2019

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Emert Number:    Z-2269-2019
Emert Status:    Announced