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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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Corporate Office

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