FDA-Device2019-05-08Class II
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), 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.
Siemens Medical Solutions USA, Inc
Hazard
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Sold states
US Nationwide Distribution
Affected count
53 total units distributed in U.S.
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2019Don't want to check this manually?
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