Z-0289-2022Class II

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

Name: Z-0289-2022 SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-08-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-08-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 on 2021-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0289-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-30
Posted: 2021-11-24
Terminated: 2024-01-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: software
FDA 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 in commerce: 64 units
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122141 122167 122156 122081 122126 122129 122090 122130 122089 122085 122037 122009 122163 122064 122038 122161 122168 122158 122144 122063 122086 122035 122041 122114 122107 122101 122108 122109 122162 122125 122011 122052 122034 122057 122145 122147 122106 122061 122051 122166 122170 122092 122004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0284-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0285-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0286-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0287-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0288-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0289-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24

Product code JAK

K190578Class IISOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM ConfidenceSiemens Medical Solutions USA, Inc. / cleared 2019-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)