Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/23/2018
Class II:

PRODUCT
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system Recall Number: Z-1745-2018

REASON
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..

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 11/8/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1385

DISTRIBUTION
Nationwide, Puerto Rico and Guam