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Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and p
Recalled May 8, 2019 · FDA recall Z-1245-2019 · Siemens Medical Solutions USA
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. · FDA Class II
Units
53 total units distributed in U.S.
Sold at
US Nationwide Distribution
Description
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.
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →