Siemens Medical Solutions USA, Inc: SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

Recall number

Z-0286-2022

Recalling firm

Siemens Medical Solutions USA, Inc

Product

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

Status

Terminated

Initiated

2021-08-30

Posted

not on file

Terminated

2024-01-16

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

Root cause

Software design

Action

Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to customers via CT021/21/S on 8/30/2021. The CSAN informs the customer of the issues health risk, the new software update version VB20_SP5 to eliminate the root causes of these problems. The software update will be distributed free of charge via CT020/21/S and CT071/21/S (update is dependent on the current software version) to all affected customers. Action to take: Siemens Healthineers has developed software update syngo.CT VB20 SP5. This new software contains workflow improvements and solutions to the previously described software issues. Please ask your local service organization if you are interested in more detailed information about the content of the software update. The new software, VB20_SP5, will be provided free of charge and will be distributed via Update CT020/21/S or CT071/20/S. Update CT071/20/S is only necessary if the system is being updated from software version VB20, VB20_SP1, or VB20_SP2 directly to VB20_SP5. Following the corrective action process CAPA, the cause of identified product issues has been eliminated and a recurrence of the identified issues is prevented. This update will be performed remotely. The remote software updates process will require approximately 45 minutes for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. If you have any questions, please contact our service organization at at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein

Quantity

121 unit

Distribution

US Nationwide distribution.

Lot, serial or model codes

Serial Numbers: 73917 73531 73126 98623 73066 74909 73152 73760 98602 98603 73476 73726 73586 73937 98616 74206 73544 73648 74156 73636 74207 73813 74360 73054 74128 73427 98600 73622 73621 73424 73423 73493 73520 73718 73296 73471 73786 74374 98620 73831 74042 74191 74405 74117 74118 73673 73497 74929 73409 73935 73642 74240 73657 73090 73030 73013 73300 73499 73535 73655 73355 73036 73908 74978 73008 74391 74209 73490 73059 73758 73513 98632 98630 74094 74098 73895 73141 74262 74158 74153 74192 73670 73051 73360 74226 74297 74234 74364 73162 73683 74068 73320 73635 73405 73547 73931 73135 73818 73873 73266 73197 74511 73591 98642 73905 73225 73938 98605 73443 74922 73886 73413 73445 74129 73261 74093 74251 73348 73430 73574 74152

510(k) numbers

["K190578"]

PMA numbers

not on file

Product code

JAK

Firm FEI

2240869

Firm city

Malvern

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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