Recall – Tomography system software issue leads to aborted scan

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 5/8/2019
Class II

PRODUCT

SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Recall Number: Z-1245-2019

SOMATOM Edge Plus, Model Number 10267000

Recall Number: Z-1246-2019

SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027

Recall Number: Z-1247-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 2/14/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
53 total units distributed in U.S.

DISTRIBUTION

US Nationwide

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