SOMATOM go.Open Pro 11061670Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869249247), received between Apr 30, 2021 and Apr 17, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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

3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Dec 22, 2022Open, Classified

   In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

   Z-1003-2023 · Root cause: Under Investigation by firm · Recall details · 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-0997-2022 · Root cause: Software change control · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO. OPEN PRO CT SYSTEM WITH A TABLETOP USED FOR RADIATION THERAPY PLANNING. THE CUSTOMER REPORTED THAT THE RTP TABLETOP SHOWS A NOTICEABLE DOWNWARD DEFLECTION WHEN LOADED WITH A PATIENT. NO PATIENT HARM HAS BEEN REPORTED IN ASSOCIATION WITH THIS EVENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909635 ↗
• MalfunctionApr 30, 2021Unstable; Unstable

  IT WAS REPORTED TO SIEMENS THAT THE CARBON PATIENT TABLE OVERLAY FOR THE RT-PLANNING CT WAS NOT STABLE ENOUGH FOR USE. THIS WAS RECOGNIZED DURING THE QUALITY ASSURANCE (QA) EVALUATION AND NO PATIENT INJURY HAS BEEN REPORTED TO SIEMENS. A DEVIATION OF THE TABLE-TOP POSITION UP TO 5MM HAS BEEN REPORTED AND IN A WORST-CASE SCENARIO, COULD LEAD TO A TREATMENT DOSE DELIVERY TO WRONG LOCATION IN LATER THERAPY WORKFLOW. THIS SCENARIO MAY OCCUR IF THIS ISSUE WASN'T DETECTED DURING QA OR LATER POSITION VERIFICATION STEPS IN THE WORKFLOW. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753789 ↗

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-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