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 Inten
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling 547 SOMATOM CT scanning systems nationwide that contain software syngo CT VA30A_SP4. These systems include the SOMATOM go.Now, go.Up, and go.All models with specific serial numbers listed in the recall. The devices are affected by a software error that may cause sporadic problems including scanning workflow interruptions, unexpected user notifications, and image artifacts during regular and interventional scanning procedures.
The software error can result in several potential patient impacts, including the need for rescans, unexpected X-ray exposure, additional contrast media administration, delayed diagnosis, and scan abortions. The recall record does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Nationwide Quantity: 547 units US Lot/code info: 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 111514 111515 111523 111525 111532 111539 111542 111546 111550 111560 111562 111564 111578 111580 111582 111586 111587 111590 111617 111634 111644 111653 111703 111712 111717 111718 111726 111754 111757 111770 111773 111780 111794 111805 111814 111815 111824 111837 111862 111901 111904 111907 111927 111940 111965 111973 111974 111980 111981 111985 111986 111989 112000 112008 112013 112023 112030 112031 112035 112040 112045 112057 112059 112060 112061 112070 112071 112074 112077 112086 112088 112101
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.