FDA Device recall Z-0962-2022
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.Al…
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.Al… by Siemens Medical Solutions Usa, citing software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0962-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-07 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
Reason
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
Identifiers
| code_info | Software syngo CT VA30A_SP4 Serial numbers: 106115 106133 106237 106260 106360 106400 106459 106464 106484 106526 1065…Software syngo CT VA30A_SP4 Serial numbers: 106115 106133 106237 106260 106360 106400 106459 106464 106484 106526 106527 106545 106562 108054 108056 108062 108076 108080 108085 108088 108095 108099 108101 108106 108108 108109 108111 108112 108113 108114 108116 108117 108118 108120 108125 108126 108128 108133 108146 108154 108158 108163 108168 108170 108174 108175 108176 108177 108178 108183 111219 111230 111232 111233 111236 111237 111249 111250 111266 111271 111273 111277 111281 111286 111289 111293 111297 111299 111302 111306 111308 111310 111313 111315 111317 111319 111323 111328 111339 111341 111345 111350 111351 111352 111355 111366 111367 111368 111369 111370 111371 111373 111378 111379 111381 111383 111386 111391 111394 111397 111398 111409 111413 111415 111416 111417 111420 111421 111426 111427 111428 111437 111438 111440 111441 111445 111446 111450 111452 111453 111454 111458 111460 111463 111465 111466 111469 111477 111485 111490 111491 111503 111504 111507 111510 111511 111 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0962-2022%22
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