FDA recall Z-1246-2019

Siemens Medical Solutions USA, Inc · Class II · device

Product

SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2019-02-14
Report date
2019-05-08
Termination date
2020-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1246-2019