Recall – Delay in diagnosis due to CT software error

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 12/1/2021
Class II

PRODUCT

SOMATOM Force with software syngo.CT VB20 Model #10742326

Recall Number: Z-0283-2022

SOMATOM Definition AS with software syngo.CT VB20 Model #8098027

Recall Number: Z-0284-2022

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

Recall Number: Z-0285-2022

SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

Recall Number: Z-0286-2022

SOMATOM Drive with software syngo.CT VB20 Model #10431700

Recall Number: Z-0287-2022

SOMATOM Confidence with software syngo.CT VB20 Model #10590100

Recall Number: Z-0288-2022

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

Recall Number: Z-0289-2022

REASON

Software Syngo.CT VB20 in the installed base, with or without Syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 8/30/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

232 units

DISTRIBUTION

U.S. Nationwide

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.