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Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Recalled May 23, 2018 · FDA recall Z-1745-2018 · Siemens Medical Solutions USA
Hazard
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force. · FDA Class II
Units
1385
Sold at
Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
Description
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
Product
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →