Z-2500-2021Class II

Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a...

Name: Z-2500-2021 Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-08-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-08-18 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up -... on 2021-08-18. FDA classified it as Class II and gives the reason as "Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2500-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-18
Posted: 2021-09-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan 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 US customers via CT024/21/S on 8/18/2021. The letter states reason for recall, helath risk and action to take: There are no workarounds available for the identified issues. Siemens Healthineers has developed software update syngo.CT VA30A_SP4 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide workflow improvements, bug fixes for the performance and stability problems observed in the installed base. The corrective action will be provided free of charge and will be distributed via of the update packages described above, depending on your current software version. Following the corrective action, the cause has been eliminated and recurrence of the identified issues are prevented. This software update will be provided to you free of charge. Software updates CT022/21/S and CT025/21/S will be performed onsite. Updates CT016/21/S and CT018/21/S will be performed remotely. The software updates process will require approximately 180 minutes for completion. 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 is not in use or when the necessary time for the update to be completed can be scheduled.
Quantity in commerce: 31 units US
Distribution: US Nationwide distribution.
Product codes and lots: US Serial Numbers: 111307, 111526, 119328, 108158, 123104, 111219, 123054, 117633, 111566, 111427, 123059, 117558, 117533, 119317, 117647, 108088, 123060, 123118, 123055, 111518, 123113, 108108, 123129, 123122, 123069, 111507, 111560, 119142, 108111, 108062, 119376. Update CT016/21/S is a remote update for the following products with software versions syngo CT VA30A SP2 or syngo CT VA30A SP2a or syngo CT VA30A SP3: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648), SOMATOM go.Sim (Model #11061660, #11061668), SOMATOM go.Open Pro (Model #11061670, #11061678). Update CT018/21/S is a remote update for the following products with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT022/21/S is an onsite update for the following product with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT025/21/S is an onsite update for the following product with software versions syngo.CT VA30A_SP2, VA30A_SP2a, syngo CT VA30A_SP3, or syngo CT VA30A_FP2 : SOMATOM X.cite (Model #11330001)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2500-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2500-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-21

Product code JAK

K200524Class IISOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOSiemens Medical Solutions USA, Inc. / cleared 2020-04-01

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)