System SOMATOM Drive 10431700Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04056869006970), received between Sep 1, 2020 and Nov 4, 2025 — classified as 2 deaths, 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

17 other recalls cover devices cleared under the same FDA submission (K161196, K190578, K230421); 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM DURING A FLASH AORTA DISSECTION PRE & POST CONTRAST SCAN. AFTER COMPLETING THE TOPOGRAM, CONTRAST INJECTION, AND PRE-MONITORING, THE SYSTEM FAILED TO REACH STANDBY AND DID NOT TRIGGER THE SCAN. THE PATIENT, A 58-YEAR-OLD MALE (110 KG), HAD TO BE REMOVED AND RESCANNED/REINJECTED ON ANOTHER DEVICE, RESULTING IN A 15-MINUTE DELAY. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466252 ↗
• MalfunctionOct 31, 2025Arcing; Radiation Overexposure; Arcing; Radiation Overexposure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. A TECHNICAL FAILURE OCCURRED DURING A PERFUSION SCAN FOR A POTENTIAL ACUTE STROKE PATIENT. IT WAS REPORTED THAT THE SCAN ABORTED TWICE DUE TO TUBE ARCING. THE 61-YEAR-OLD FEMALE PATIENT HAD TO BE REMOVED AND RESCANNED/REINJECTED ON ANOTHER DEVICE, RESULTING IN A 40-MINUTE DELAY. NO MEDICAL INTERVENTION WAS REQUIRED AND NO NEGATIVE HEALTH CONSEQUENCES FOR THE PATIENT ARE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434636 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SIEMENS BECAME AWARE OF A MALFUNCTION THE OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. ON (B)(6) 2024, DURING A PATIENT SCAN THE MONITOR CEILING SYSTEM (MCS) HOLDER AXIS SLIPPED A FEW CENTIMETERS OUT OF THE TUBE SHAFT. THE MCS DID NOT COMPLETELY DETACH FROM THE CEILING, HOWEVER, THE OPERATOR, WHO WAS LOCATED UNDER THE SYSTEM, WAS HIT. THE OPERATOR REPORTED A SORE SHOULDER AS A RESULT OF THIS INCIDENT. SIEMEN WAS NOT PROVIDED A REPORT OF IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED AND IF MEDICAL TREATMENT WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864269 ↗
• MalfunctionFeb 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. ON (B)(6) 2024, AN INCIDENT OCCURRED IN WHICH A PART OF THE COVER OF THE SEALING MOUNTED SCREEN HOLDER FELL OFF AND ONTO THE PATIENT'S HEAD. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED AND NO MEDICAL TREATMENT WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710098 ↗
• MalfunctionMay 12, 2023No Device Output; Output Problem; No Device Output; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. ON (B)(6) 2023, AFTER COMPLETION OF A SCAN OF AN 11-YEAR-OLD FEMALE PATIENT, RECONSTRUCTION OF THE IMAGES WAS NOT POSSIBLE DUE TO A FROZEN SYSTEM. THE CUSTOMER CONTACTED SIEMENS HEALTHINEERS SERVICE AND PERFORMED A SYSTEM RESTART; HOWEVER, RECONSTRUCTION OF THE SCANNED IMAGES WAS STILL NOT POSSIBLE BECAUSE OF AN ERROR MESSAGE OF THE SCAN PROTOCOL. AS A RESULT, A RESCAN OF THE PATIENT WAS NECESSARY. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918357 ↗
• DeathNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. IT WAS REPORTED THAT A FEMALE PATIENT WAS SCHEDULED FOR A CT SCAN WITH CONTRAST MEDIUM. AFTER THE CONTRAST MEDIUM INJECTION, THE PATIENT DEVELOPED DYSPNEA AND SOON AFTER REQUIRED CPR FOR APPROXIMATELY 45 MINUTES. THE HOSPITAL REPORTED THAT THE PATIENT DIED. ALTHOUGH THE PATIENT MOST LIKELY DIED DUE TO AN ALLERGIC REACTION TO THE CONTRAST MEDIUM, A TECHNICAL INVESTIGATION WAS INITIATED. THE LOG FILES FROM THREE WEEKS PRIOR TO THE EVENT UP TO (B)(6) 2022, WERE ANALYZED. NO SCAN ABORTS WERE DETECTED ON (B)(6) 2022, ONLY DURING RESUME WHICH WAS INITIATED BY THE CUSTOMER. TWENTY-SIX PATIENTS WERE SCANNED ON (B)(6) 2022, WITHOUT ANY PROBLEMS. NO SCAN ABORTS WERE DETECTED IN THE PERIOD FROM (B)(6) 2022, EITHER. BASED ON THE AVAILABLE INFORMATION, THE DEATH OF THE PATIENT WAS NOT RELATED TO THE SOMATOM DRIVE CT SYSTEM.

  Patient problems: Cardiac Arrest; Hypersensitivity/Allergic reaction

  MAUDE report 15832965 ↗
• InjurySep 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. IT WAS REPORTED THAT A PATIENT BROKE THROUGH THE CT GANTRY PLEXI-RING (SCAN WINDOW) WITH HIS KNEE DURING AN EXAMINATION ON (B)(6) 2022. THE HOSPITAL DID NOT USE ANY STRAPS TO PREVENT THE PATIENT FROM MOVING AS THE PATIENT WAS IN A GREAT AMOUNT OF PAIN. DURING THE SCAN, THE PATIENT EXPERIENCED DISTRESS AND KICKED HIS KNEE INTO THE PLEXI-RING, BREAKING THROUGH THE PLEXI-RING AND MEETING THE ROTATING PART OF THE GANTRY. THE PATIENT WAS IMMEDIATELY SENT TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND RECEIVED STITCHES IN THE KNEE BEFORE BEING SENT HOME. WE ARE UNAWARE OF ANY FURHTER IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. THERE WAS NO DEVICE MALFUNCTION REPORTED. THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Laceration(s)

  MAUDE report 15474579 ↗
• InjurySep 19, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. A 66 YEAR OLD FEMALE PATIENT WAS EXAMINED ON (B)(6) 2022. THE PATIENTS FINGER WAS STUCK BETWEEN THE TABLE MATTRESS AND THE FREE SPACE RESULTING IN A SOFT TISSUE DEFORMATION AND OPEN WOUND WITH SCRATCHES. IT IS REPORTED THAT THE PATIENT'S FINGER IS IN GOOD CONDITION AND NO MEDICAL INTERVENTION WAS REQUIRED. THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 15445241 ↗
• InjuryJun 2, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. IT WAS REPORTED THAT A CONFUSED PATIENT UNDERWENT A CT EXAMINATION OF THE ABDOMEN. THE EXAMINATION WAS CONDUCTED IN WHICH THE PATIENT WAS MOVED TWICE THROUGH THE DEVICE WITHOUT ANY PROBLEMS. AFTER ASKING THE RADIOLOGIST, THE PATIENT WAS ALLOWED TO LEAVE THE TABLE. WHEN THE PATIENT TABLE WAS DRIVING OUT OF THE DEVICE, THE PATIENT UNEXPECTEDLY FOLDED HER KNEE SO THAT IT COULD NO LONGER PASS THROUGH THE DEVICE. THE KNEE BECAME STUCK AND THE PLEXI GLASS OF THE CT SCANNER BROKE. AS A RESULT, THE PATIENT SUFFERED AN INJURY TO THE LEFT KNEE. FURTHERMORE, IT WAS REPORTED THAT THE PATIENT WAS NOT FIXATED AS RECOMMENDED IN THE INSTRUCTION FOR USE. THE EMERGENCY PHYSICIAN EVALUATED THE PATIENT AND SHE WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR FURTHER FOLLOW-UP. THE PATIENT SUFFERED PARTIAL TISSUE LOSS APPROXIMATELY 6CM X 4.5CM IN DIAMETER UP TO THE PATELLA. THE LESION IS CLEAR WITH NO SIGNS OF INFECTION AND THE WOUND ENVIRONMENT IS INTACT. THE PATIENT IS CURRENTLY UNDER THE CARE OF A PHYSICIAN AND FURTHER TREATMENT HAS NOT YET BEEN DETERMINED.

  Patient problems: Laceration(s)

  MAUDE report 14573240 ↗
• InjuryApr 4, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AFTER COMPLETION OF THE CT EXAMINATION, THE PATIENT PUSHED HIS KNEE INTO THE SYSTEM SCAN WINDOW (PLEXI RING) AS THE HOSPITAL STAFF WERE TRYING TO RESTRAIN HIM. THE EVENT RESULTED IN A MODERATE INJURY TO THE PATIENT. THE PATIENT SUSTAINED A 3.5 CM LACERATION TO THE ANTERIOR PORTION OF HIS KNEE. THE WOUND WAS TREATED AND CLOSED WITH THREE (3) SUTURES AND THREE (3) STAPLES. ASIDE FROM THIS INJURY, NO OTHER NEGATIVE HEALTH CONSEQUENCES WERE REPORTED TO SIEMENS. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE PATIENT WAS NOT FIXATED PROPERLY BEFORE THE PROCEDURE AS RECOMMENDED IN THE SYSTEM USER MANUAL. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Laceration(s)

  MAUDE report 13995898 ↗
• DeathMar 1, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT DURING A PATIENT PROCEDURE ON (B)(6) 2022 AT 5:23 PM, THE CT SCANNER MALFUNCTIONED. THE PATIENT, A (B)(6) MALE, HAD RECEIVED 90ML OF CONTRAST MEDIA (OMNIPAQ 300) ON THE TABLE WITH A THREE PHASE SCAN PLANNED. DURING THE SECOND PHASE THE USER REPORTED THAT THE SCAN ABORTED. THE USER STATED THAT THEY REPLANNED/RESTARTED THE SCAN, BUT THE SCAN ABORTED AGAIN. WHEN THIS OCCURRED, THE ISSUE WAS REPORTED TO SIEMENS SERVICE. THE SYSTEM WAS REPAIRED BY REPLACING THE X-RAY TUBE. SIEMENS WAS LATER INFORMED THAT THE PATIENT SUFFERED FROM ADVANCED STAGE CANCER AND HAD PASSED AWAY LATER DURING THE EVENING OF (B)(6) 2022, OR DURING THE EARLY MORNING ON (B)(6) 2022. THE EXACT DATE AND TIME OF THE PATIENT'S DEATH IS UNKNOWN TO SIEMENS. THE PATIENT HAD METASTATIC PANCREATIC CANCER, A PERFORATED BLADDER, AND BLOOD CLOTS IN HIS LUNGS. SIEMENS ASKED IF THE FAILED SCAN COULD HAVE CONTRIBUTED TO THE PATIENT'S DEATH AND WAS TOLD THAT IT WAS NOT CLEAR AS THE PATIENT WAS VERY ILL, BUT NOT ACQUIRING THE DATA MAY HAVE CONTRIBUTED. THE SCAN WAS REQUESTED TO SEE IF THERE WAS EVIDENCE OF A BLEED, AND THE ACQUIRED DATA DIDN'T SHOW ANY. IT IS CURRENTLY UNKNOWN IF THE SCANNER CAUSED O

  Patient problems: Insufficient Information

  MAUDE report 13634370 ↗
• MalfunctionJun 2, 2021Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED TO SIEMENS THAT THE HOSPITAL INHOUSE TECHNICIAN RECEIVED AN ELECTRICAL SHOCK WHILE WORKING INSIDE THE POWER DISTRIBUTION CABINET (PDC) FOR THE REPORTED CT SCANNER. THE KEY TO THE PDC WAS STORED ONSITE. THE TECHNICIAN RECEIVED THE SHOCK WHEN HE CLOSED (RESET) THE F1 FUSE BY HAND. AFTER THE INCIDENT, THE FACILITY MONITORED HIS HEART RATE FOR AN UNKNOWN DURATION OF TIME UNTIL IT WAS DETERMINED HIS HEART RATE WAS NORMAL. THE FACILITY DID NOT REPORT ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE INCIDENT. IT WAS FURTHER REPORTED THAT THE TECHNICIAN WAS NOT CERTIFIED TO WORK INSIDE THE PDC. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919214 ↗
• MalfunctionApr 9, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT DURING A DUAL ENERGY CT CONTRAST SCAN OF A (B)(6) MALE PATIENT USING THE SOMATOM DRIVE SYSTEM, THE RUNOFF SCAN COULD NOT BE LOADED AFTER MONITORING AND THE EXAMINATION WAS ABORTED. THE SCAN HAD TO BE REPEATED USING A DIFFERENT CT SYSTEM AND ADDITIONAL CONTRAST MEDIA WAS ADMINISTERED. THE SECOND LOW DOSE OVERVIEW SCAN (TOPOGRAM) WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT SUFFER ANY ADVERSE HEALTH ISSUES DUE TO THE DELAY IN THE EXAMINATION, ADDITIONAL LOW DOSE X-RAY EXPOSURE AND ADDITIONAL CONTRAST MEDIA. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640518 ↗
• MalfunctionFeb 9, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT DURING A CT EXAMINATION OF A (B)(6) YEAR OLD CHILD, THE SCAN ABORTED, AND THE CHILD HAD TO BE RESCANNED. NO OTHER INJURY WAS REPORTED BESIDE THE ADDITIONAL X-RAY DOSE FROM THE RESCAN. THIS REPORT HAS BEEN FILED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300245 ↗
• InjurySep 1, 2020Break; Break

  IT WAS REPORTED TO SIEMENS THAT AFTER COMPLETION OF A CT SCAN, THE CUSTOMER WAS MOVING THE PATIENT OUT OF THE GANTRY AND THE PATIENT REACTED BY PUSHING AGAINST THE PLEXI-RING AND GANTRY COVER. DUE TO THE EXTERNAL FORCE, THE CT PLEXI-RING AND GANTRY COVER BROKE. THE PATIENT SUBSEQUENTLY SUSTAINED LACERATIONS TO THE HAND AND KNEE AS A RESULT. THE PATIENT WAS TAKEN BACK TO THE EMERGENCY DEPARTMENT OF THE FACILITY FOR MEDICAL TREATMENT OF THE INJURIES; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED TO SIEMENS. ACCORDING TO THE OPERATOR, BEFORE THE CT SCAN, THE PATIENT WAS INITIALLY ADMITTED TO THE EMERGENCY DEPARTMENT. THE REASON FOR ADMISSION IS UNKNOWN. DURING THE CT EXAMINATION, THE PATIENT'S ARMS WERE NOT FIXATED, AND THE PATIENT WOULD NOT LISTEN TO THE CT TECHNICIAN'S INSTRUCTIONS TO STOP MOVING.

  Patient problems: Laceration(s)

  MAUDE report 10475942 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161196, K190578, K230421. One submission often covers many models, so check the product and lot details in each record.

• Z-0475-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Definition Edge -Computed tomography system Model 10590000
• Z-0474-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Edge Plus-Computed tomography system Model 1026700
• Z-0473-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Definition AS-Computed tomography system Model 8098027
• Z-0472-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Confidence -Computed tomography systems Model 10590100
• Z-0289-2022 · Aug 30, 2021 · Terminated
  SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
• Z-0288-2022 · Aug 30, 2021 · Terminated
  SOMATOM Confidence with software syngo.CT VB20 Model #10590100
• Z-0287-2022 · Aug 30, 2021 · Terminated
  SOMATOM Drive with software syngo.CT VB20 Model #10431700
• Z-0283-2022 · Aug 30, 2021 · Terminated
  SOMATOM Force with software syngo.CT VB20 Model #10742326
• Z-0284-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
• Z-0286-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
• Z-0285-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
• Z-0771-2021 · Nov 24, 2020 · Terminated
  SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
• Z-3025-2020 · Jun 22, 2020 · Terminated
  Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #1059000
• Z-0406-2020 · Oct 7, 2019 · Terminated
  Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition E
• Z-2440-2019 · Jul 25, 2019 · Terminated
  syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM De

…and 2 more.