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