SOMATOM go.Up 11061628Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869051321), received between Jul 28, 2020 and Sep 28, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Application Program Version or Upgrade Problem” (1 report).

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

5 other recalls cover devices cleared under the same FDA submission (K163296); 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 ↗

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.

• InjurySep 28, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM GO.UP CT SYSTEM. DURING A TOPO SCAN, IT WAS REPORTED THAT THE PATIENT'S ARM PIERCED THE PLEXI RING AND EXTENDED INTO THE GANTRY. THE PATIENTS ARM CAME INTO CONTACT WITH ROTATING PARTS IN THE GANTRY, RESULTING IN A FRACTURE TO THE LEFT ARM. THE PATIENT WAS EVALUATED BY MEDICAL STAFF AND WILL RECEIVE FURTHER TREATMENT AT A LATER TIME. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 15500555 ↗
• MalfunctionJul 28, 2020Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  IT WAS REPORTED TO SIEMENS THAT DUE TO A SOFTWARE PROBLEM, WHEN THE SOFTWARE VERSION IS UPDATED FROM (B)(4), THE "CALIBRATION OFFSET PARAMETER" WHICH DETERMINES THE DISTANCE BETWEEN THE EXTERNAL LASERS FOR PATIENT MARKING AND THE CT CENTRAL IMAGE PLANE, IS SILENTLY OVERWRITTEN TO THE FACTORY DEFAULT SETTINGS (50.0CM). AS OF THE DATE OF THIS REPORT, NO INJURY HAS BEEN REPORTED TO SIEMENS. IN A WORST-CASE SCENARIO, IF THE USER DOESN'T REALIZE THIS CHANGE AND DOES NOT PERFORM A RE-CALIBRATION, THIS CHANGE MAY RESULT IN AN INCORRECT PATIENT MARKING AND SUBSEQUENTLY TO A RADIATION DOSE APPLIED TO WRONG LOCATION DURING THE CANCER TREATMENT. THIS WORST-CASE SCENARIO CAN ONLY OCCUR IF SOME OTHER PROCESS STEPS SUCH AS, POSITION VERIFICATION AT THE LINEAR ACCELERATOR BEFORE THE TREATMENT, DO NOT CLEARLY SHOW ANY DEVIATION. THIS PROBLEM IS RELATED TO THE FOLLOWING SOFTWARE/WORKFLOW: SYNGO.VIA RT IMAGE SUITE CAN BE USED AS ADVANCED APPLICATION ON SOMARIS10 CT SCANNERS. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10333382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163296. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-1939-2018 · Apr 20, 2018 · Terminated
  SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
• Z-1940-2018 · Apr 20, 2018 · Terminated
  SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
• Z-0714-2018 · Oct 2, 2017 · Terminated
  SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer r
• Z-0713-2018 · Oct 2, 2017 · Terminated
  SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer re