FDA recall Z-1745-2018

Product

SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system

Reason for recall

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.

Distribution

Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2017-11-08

Report date

2018-05-23

Termination date

2023-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1745-2018