Siemens Medical Solutions USA, Inc: 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.

Recall number

Z-2500-2021

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.

Status

Open, Classified

Initiated

2021-08-18

Posted

not on file

Terminated

not on file

Reason

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

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

31 units US

Distribution

US Nationwide distribution.

Lot, serial or model codes

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)

510(k) numbers

["K200524"]

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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