SOMATOM go.Sim 11061660Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869249230), received between Nov 18, 2022 and Nov 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Scratched Material” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K192061, K211373, K233650, K250822); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 7, 2022Open, Classified

   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

   Z-0962-2022 · Root cause: Software design · FDA record ↗

2. Mar 7, 2022Terminated

   Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

   Z-0996-2022 · Root cause: Software change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2022Scratched Material; Scratched Material

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM GO.SIM CT SYSTEM. IT WAS REPORTED THAT A CT TECHNOLOGIST CUT HER RIGHT INDEX FINGER ON THE UNDERSIDE OF THE RADIATION TABLETOP DUE TO A SHARP EDGE WHILE REMOVING THE HEADREST. THE TECHNOLOGISTS' FINGER WAS CLEANED, AND BANDAGED, AND NO FURTHER MEDICAL TREATMENT WAS REQUIRED. THE SERVICE ENGINEER CHECKED THE INVOLVED HARDWARE, AND NO VISIBLE IRREGULARITIES WERE OBSERVED ON THE TABLE, TABLETOP, OR HEADREST. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. FOLLOWING THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED IF A DEVICE MALFUNCTION IS IDENTIFIED.

  Patient problems: Abrasion

  MAUDE report 15825368 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192061, K211373, K233650, K250822. One submission often covers many models, so check the product and lot details in each record.

• Z-1239-2026 · Dec 19, 2025 · Open, Classified
  SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
• Z-1003-2023 · Dec 22, 2022 · Open, Classified
  Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.
• Z-0995-2022 · Mar 7, 2022 · Terminated
  syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo
• Z-1253-2021 · Mar 3, 2021 · Terminated
  Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 110616