SOMATOM go.Up 11061620Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869051314), received between May 21, 2021 and Dec 5, 2024 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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

6 other recalls cover devices cleared under the same FDA submission (K163296, 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. 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 · 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-0995-2022 · Root cause: Software change control · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO. UP CT SYSTEM. THE USER REPORTED THAT A SCAN OF AN 84-YEAR-OLD FEMALE POTENTIAL STROKE PATIENT WAS NOT POSSIBLE AFTER CREATING THE TOPO. THE PREPARATION SYMBOL (GREEN CIRCLE) WAS SPINNING; BUT NEVER CHANGED. ACCORDING TO THE USER, THIS RESULTED IN A 30-MINUTE DELAY IN DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852121 ↗
• InjuryAug 10, 2023Use 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 EXAMINATION, WHILE THE TABLE WAS BEING DRIVEN, THE PATIENT¿S FINGER WAS PINCHED BETWEEN THE TABLETOP SUPPORT AND THE TABLETOP. AS A RESULT, THE PATIENT SUFFERED A LACERATION TO THE FINGER WHICH REQUIRED FOUR STITCHES. WE ARE UNAWARE OF ANY FURTHER IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: Laceration(s)

  MAUDE report 17497611 ↗
• InjuryMay 26, 2021Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

  IT WAS REPORTED TO SIEMENS THAT AFTER INJECTION OF A CONTRAST MEDIUM DURING A ROUTINE CT SCAN, THE PATIENT STARTED TO CHOKE ON THE PATIENT TABLE OF THE SOMATOM SYSTEM. OVER TIME, THE PATIENT'S CONDITION DETERIORATED FURTHER. THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION TO REVIVE HIM. THE SITUATION APPEARED TO BE A SERIOUS ALLERGIC REACTION TO THE CONTRAST MEDIUM. THE PATIENT WAS STABILIZED WITHOUT ANY PERMANENT HEALTH CONSEQUENCES. THE USER ALLEGED THAT THE INTERCOM SYSTEM USED TO COMMUNICATE WITH PATIENTS DURING EXAMINATION, WAS EMITTING NOISY FEEDBACK DURING THE EXAMINATION, AND DISTURBED COMMUNICATION BETWEEN THE USER AND THE PATIENT. THE USER REPORTED THE COMMUNICATION INTERFERENCE MAY HAVE CONTRIBUTED TO THE USER MISSING THE FIRST SIGNS OF THE PATIENT'S ALLERGIC REACTION AND DISTRESS. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11886039 ↗
• DeathMay 21, 2021Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED TO SIEMENS THAT A PLANNED CT EXAMINATION OF AN EMERGENCY PATIENT FROM THE FACILITY ICU WAS NOT POSSIBLE BECAUSE THE CT COULD NOT BE STARTED DUE TO THE CALCULATED TUBE COOLING WAIT TIME. THE PATIENT HEALTH STATUS WAS CRITICAL. THE USER REPORTED THAT THE CT SCAN WAS PLANNED ONE WEEK EARLIER BUT WAS POSTPONED DUE THE PATIENT'S CONDITION AND LACK OF TRANSPORTATION CAPABILITY. A SIGNIFICANT DELAY IN DIAGNOSIS (1.5 HOURS) WAS ASSOCIATED WITH THE TUBE COOLING WAIT TIME WARNING. AFTER THE USER CONTACTED TECHNICAL SUPPORT, THE SCAN WAS ABLE TO BE COMPLETED. THE USER DID NOT ALLEGE A PRODUCT MALFUNCTION. UNFORTUNATELY, THE PATIENT PASSED AWAY IN THE ICU AT AN UNKNOWN TIME AFTER THE SCAN ON (B)(6) 2021. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 11863495 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163296, 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-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-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-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-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
• 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