SOMATOM go.Top 11061640Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04056869151571), received between Oct 29, 2021 and Jun 3, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

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

19 other recalls cover devices cleared under the same FDA submission (K173632, 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, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM GO.TOP CT SCANNER. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT HIT THE PLEXIGLASS RING LOCATED IN THE CENTER OF THE GANTRY WITH HIS KNEE, RESULTING IN DAMAGE TO THE COMPONENT. THE PATIENT SUSTAINED MINOR ABRASIONS TO THE KNEE, WHICH WERE TREATED WITH MINOR FIRST AID. NO SERIOUS OR LONG-TERM HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Abrasion

  MAUDE report 25373359 ↗
• MalfunctionDec 5, 2024Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO. TOP CT SYSTEM. A 79-YEAR-OLD FEMALE PATIENT WAS ON THE SCANNER FOR A CONTRAST MEDIA GUIDED STROKE EXAMINATION. THE EXAMINATION WAS NOT POSSIBLE DUE TO A TECHNICAL ISSUE AND THE PATIENT WAS SENT TO ANOTHER FACILITY. A STROKE WAS LATER EXCLUDED, AND A UTI INFECTION WAS DIAGNOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852115 ↗
• InjuryJun 21, 2024Use 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.TOP CT SYSTEM. ON (B)(6) 2024, DURING AN EXAMINATION OF A 59-YEAR-OLD MALE PATIENT, THE PLEXIGLASS RING OF THE SCANNER WAS DAMAGED. THE PATIENT BENT HIS KNEE AS THE TABLE MOVED TOWARD THE GANTRY DURING THE TOPOGRAM SCAN. AS A RESULT, THE PLEXIGLASS RING BROKE AND THE PATIENT SUFFERED A SOFT TISSUE INJURY TO THE KNEE WHICH REQUIRED STITCHES.

  Patient problems: Laceration(s)

  MAUDE report 19582679 ↗
• MalfunctionApr 12, 2024Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO.TOP CT SYSTEM. ON (B)(6) 2024, THE CUSTOMER STARTED A STROKE STUDY OF A 65-YEAR-OLD FEMALE AND COMPLETED THE STUDY. THE RECONSTRUCTION OF THE IMAGES TOOK APPROXIMATELY 25 TO 27 MINUTES RESULTING IN A DELAY OF THE PROCEDURE. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF THE PATIENT DUE TO THE DELAY, HOWEVER, IN A WORST-CASE SCENARIO THE DELAY COULD HAVE SERIOUS HEALTH CONSEQUENCES FOR A STROKE PATIENT. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION TO CONDUCT A THOROUGH INVESTIGATION OF THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094948 ↗
• MalfunctionAug 18, 2023Circuit Failure; Intermittent Continuity; Circuit Failure; Intermittent Continuity

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO.TOP CT SYSTEM. ON (B)(6), 2023, AN EMERGENCY STROKE PATIENT WAS PLANNED FOR A CT SCAN, HOWEVER, THE SCAN WAS INTERRUPTED WITH AN ERROR MESSAGE. THE CUSTOMER CONTACTED SIEMENS FOR SUPPORT, AND IT WAS DETECTED THAT THE CONNECTION TO THE CONTROL BOX WAS LOST. AFTER THE CONNECTION WAS RESEATED, COMPLETION OF THE SCAN WAS POSSIBLE. AS A RESULT OF THE ERROR MESSAGE, THE SCAN WAS DELAYED FOR APPROXIMATELY TWO MINUTES. NO NEGATIVE HEALTH CONSEQUENCE WAS REPORTED FOR THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571897 ↗
• MalfunctionDec 19, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO.TOP CT SYSTEM. SIEMENS WAS NOTIFIED ABOUT A CUSTOMER ISSUE USING THE MYNEEDLE GUIDE CT INTERVENTION APPLICATION. ON (B)(6) 2022, THE IMAGE ORIENTATION WAS FLIPPED WHEN THE CUSTOMER USED THE "MOVE TO" SELECTED SLICE POSITION. THE CUSTOMER RECOGNIZED THE FLIPPED IMAGES AND ADDITIONAL I-FLUORO IMAGES WERE TAKEN DURING THE PROCEDURE TO ENSURE ANGLES IN THE CORRECT DIRECTION. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003812 ↗
• MalfunctionDec 16, 2022Computer Software Problem; Loss of Data; Computer Software Problem; Loss of Data

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO. TOP CT SYSTEM. THE CUSTOMER REPORTED THAT THE IMAGES OF A CTA HEAD STROKE PROTOCOL STUDY PERFORMED ON (B)(6) 2022, COULD NOT BE RECONSTRUCTED ON (B)(6) 2022. THE PATIENT WAS SCANNED WITH TWO SPIRALS. BOTH RAW DATA FILES DID NOT LATER EXIST IN THE IMAGE RECONSTRUCTION SYSTEM (IRS). THE PATIENT IS A PREGNANT FEMALE (APPROX. WEEK 32 AT TIME OF SCAN) AND WAS NOT RESCANNED. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED. WE CONSIDER PREGNANT PATIENTS AS A SPECIAL POPULATION GROUP WHO NEEDS TO BE PROTECTED. THEREFORE, THIS REPORT IS FILED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996203 ↗
• InjuryDec 20, 2021Failure to Select Signal; Failure to Select Signal

  IT WAS REPORTED TO SIEMENS THAT THE MOBILE TABLET ASSOCIATED WITH THE SOMATOM GO. TOP LOST ITS WIRELESS CONNECTION TO THE CT SCANNER DURING AN INTERVENTIONAL BIOPSY PROCEDURE ON (B)(6) 2021. THE PANCREAS BIOPSY WAS CONTINUED WITHOUT THE OPTIONAL TABLET, USING THE CONSOLE OF THE SCANNER INSTEAD. FURTHERMORE, IT WAS REPORTED THAT THE USER DIDN'T USE THE MEASUREMENT FUNCTION AT THE SCANNER CONSOLE. THE DISTANCE THAT NEEDED TO BE MEASURED HAD BEEN ASSESSED VISUALLY ONLY. THE INACCURACY OF THIS METHOD RESULTED IN ADDITIONAL AND UNNECESSARY PATIENT BLEEDING. ASIDE FROM THE ADDITIONAL BLOOD LOSS, THE PATIENT DID NOT SUFFER ANY NEGATIVE HEALTH CONSEQUENCES. IT WAS DECIDED THAT THE PATIENT SHOULD STAY ONE ADDITIONAL DAY AT THE HOSPITAL FOR MONITORING. THE PATIENT WAS DISCHARGED AFTER THE 24-HOUR FOLLOW-UP EXAMINATION IN GOOD HEALTH AND WITHOUT ADVERSE SYMPTOMS. IN A WORSE-CASE SCENARIO, THE PATIENT BLEEDING COULD BECOME LIFE-THREATENING IF THE MAJOR VESSELS (E.G., AORTA) WAS PUNCTURED. THIS EVENT HAS BEEN REPORTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13042780 ↗
• InjuryOct 29, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT DURING A CT EXAMINATION OF A PATIENT WITH A PLASTER LEG CAST, THE PATIENT RAISED HER CASTED LEG AND HIT THE CT SCAN WINDOW (PLEXI RING). THE PATIENT WAS NOT FIXATED PROPERLY, AS RECOMMENDED IN THE CT SYSTEM USER MANUAL. AS A RESULT, THE PLEXI RING WAS BROKEN, AND THE PATIENT'S CASTED LEG CONTACTED THE ROTATING GANTRY. PART OF THE PLASTER CAST WAS REMOVED BY THE ROTATING GANTRY AND THE PATIENT SUSTAINED INJURY TO HER LEG. THE PATIENT'S WOUND WAS APPROXIMATELY 5 CENTIMETERS IN LENGTH AND REQUIRED SUTURES TO TREAT IT. IT WAS FURTHER REPORTED TO SIEMENS THAT THERE WAS NO PERMANENT DETERIORATION TO THE PATIENT'S HEALTH STATUS DUE TO THIS EVENT. THERE IS NO ALLEGATION OF SYSTEM MALFUNCTION BY THE USER. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Laceration(s)

  MAUDE report 12723478 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173632, 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
• Z-0265-2020 · Sep 24, 2019 · Terminated
  SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
• Z-2399-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer rec
• Z-2403-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2402-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2405-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2401-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2404-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2400-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction o
• Z-1922-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process c
• Z-1921-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process c
• Z-1920-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process c
• Z-1919-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cr

…and 4 more.