FDA-Device2018-05-23Class II
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Siemens Medical Solutions USA, Inc
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.
Sold states
Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
Affected count
1385
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1745-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief