System SOMATOM Definition AS 08098027Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04056869003665), received between Jul 8, 2020 and Sep 2, 2026 — classified as 1 death, 22 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (11 reports).

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

12 other recalls cover devices cleared under the same FDA submission (K130901, 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.

Recalls naming this device

1. Nov 19, 2021Open, Classified

   Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

   Z-0473-2022 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Unintended Electrical Shock

  Patient problems: Burn(s)

  MAUDE report 50561712 ↗
• MalfunctionJul 1, 2026Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. IT WAS REPORTED THAT, DURING AN EXAMINATION OF AN EMERGENCY PATIENT, AN EXTERNAL PATIENT MONITORING DEVICE (INTELLIVUE PATIENT MONITOR MX100) FELL FROM THE PATIENT HANDLING SYSTEM (PHS) AND STRUCK THE GANTRY SEALING RING. AS A RESULT OF THE IMPACT, THE SEALING RING WAS PENETRATED, AND CONTACT OCCURRED BETWEEN THE MONITORING DEVICE AND THE ROTATING PORTION OF THE GANTRY. THE PATIENT MONITOR WAS POSITIONED ON THE PATIENT HANDLING SYSTEM BETWEEN THE PATIENT'S LEGS WITHOUT BEING SECURED BY A RETAINING STRAP. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676823 ↗
• MalfunctionJun 3, 2026Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. THE CUSTOMER REPORTED A TECHNICAL MALFUNCTION RESULTING IN A GANTRY DOWN CONDITION AND AN UNSUCCESSFUL SYSTEM CHECKUP. AT THE TIME OF THE EVENT, AN ACUTE STROKE PATIENT WAS UNDERGOING A PERFUSION EXAMINATION. DUE TO THE TECHNICAL ISSUE, ONLY A PARTIAL PERFUSION SCAN AND PARTIAL CONTRAST MEDIA INJECTION WERE COMPLETED. THE EXAMINATION COULD NOT BE FINISHED ON THE AFFECTED SYSTEM. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER CT SYSTEM AND RESCANNED AFTER A DELAY OF APPROXIMATELY 20 MINUTES. ACCORDING TO THE INFORMATION PROVIDED, NO NEGATIVE HEALTH CONSEQUENCES WERE CAUSED BY THE DELAY IN THE EXAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375110 ↗
• InjuryMay 26, 2026Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING A SOMATOM DEFINITION AS CT SYSTEM. ACCORDING TO THE CUSTOMER THE CT EXAMINATION WAS PERFORMED DUE TO HEMATURIA. DURING A WHOLE-BODY SCAN, AFTER THE PATIENT HAD ALREADY BEEN POSITIONED IN THE GANTRY, THE OPERATOR IN THE CONTROL ROOM PRESSED THE MOVEMENT BUTTON ON THE CONTROL BOX IN ORDER TO MOVE THE PATIENT HANDLING SYSTEM (PHS). WHILE THE PHS WITH THE PATIENT WAS MOVING BACK FROM THE TABLETOP, THE PATIENT¿S ELBOW DANGLED OFF THE TABLETOP AND WAS FRACTURED. THE INJURY WAS DISCOVERED ONLY AFTER COMPLETION OF THE TABLE MOVEMENT AS THE PATIENT HAD SUFFERED A STROKE AND WAS UNABLE TO SPEAK.

  Patient problems: Limb Fracture

  MAUDE report 25279849 ↗
• MalfunctionApr 17, 2026Unintended Collision

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. THE CUSTOMER REPORTED THAT, DURING A PATIENT SCAN, THE SLIDING GANTRY OF THE CT SYSTEM COLLIDED WITH A TABLE FROM THE MANUFACTURER MAQUET GMBH. NO ADVERSE HEALTH EFFECTS FOR THE PATIENT WERE REPORTED, AND NO RESCAN WAS NECESSARY. MATERIAL DAMAGE TO THE CT SYSTEM COVERS AND INTERNAL COMPONENTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909461 ↗
• InjurySep 16, 2025Use 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 DEFINITION AS CT SYSTEM. ON (B)(6) 2025, A PATIENT OF UNKNOWN SEX AND AGE SUSTAINED AN INJURY TO THE ARM DUE TO A BROKEN COVER OF THE PATIENT HANDLING SYSTEM (PHS). ACCORDING TO THE AVAILABLE INFORMATION, DURING THE TABLE MOVEMENT THE BEDSHEET BECAME ENTANGLED IN THE TABLE, CAUSING A SUPERFICIAL SKIN INJURY WITH MINOR BLEEDING, WHICH STOPPED SPONTANEOUSLY. THE WOUND WAS DISINFECTED, AND NO FURTHER MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: Abrasion

  MAUDE report 23062051 ↗
• InjuryJan 17, 2025Use 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 DEFINITION AS CT SYSTEM. ON (B)(6) 2025, A 77-YEAR-OLD PATIENT UNDERWENT AN EXAMINATION. DURING THE UNLOAD, THE PATIENTS¿ ARM SLIPPED DOWN AND WAS SQUEEZED BETWEEN THE BED AND THE GANTRY RESULTING IN A FRACTURE OF THE RIGHT ARM HUMERUS. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS NOT FIXED AND NOT OBSERVED AS RECOMMENDED PER THE SYSTEM OPERATOR MANUAL.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 21178119 ↗
• InjuryOct 31, 2024Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. THE CUSTOMER REPORTED ON (B)(6) 2024, THAT ON THE SAME DAY, WHILE UNLOADING THE PATIENT, THE INTERVENTIONAL PANEL, WHICH WAS LYING IN THE MIDDLE OF THE GANTRY BORE, WAS PRESSED THRU THE SEALING RING. THE SEALING RING WAS BROKEN BY ROTATING PARTS AND CAUSED A BRUISED ELBOW TO THE PATIENT.

  Patient problems: Bruise/Contusion

  MAUDE report 20578348 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS ON (B)(6) 2024, THAT DURING THE PAST SIX WEEKS TWO ADVERSE EVENTS OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. A CUSTOMER REPORTED THAT TWO PATIENTS HAD THEIR FINGERS CAUGHT BETWEEN THE TABLE-TOP AND THE TOP-SUPPORT OF THE PHS (PATIENT HANDLING SYSTEM, PATIENT TABLE) DURING THE PATIENT UNLOAD AFTER THE CT SCAN. THE FIRST PATIENT SUFFERED AN INJURY TO THE DIGITUS MINIUMUS. THE PATIENT¿S FINGER WAS GLUED AND TREATED WITH STIPS. NO STITCHES WERE REQUIRED. THE SECOND PATIENT SUFFERED AN INJURY TO THE INDEX FINGER. THE PATIENT WAS X-RAYED IMMEDIATELY WITHOUT FINDING. THE PATIENT WAS ON BLOOD THINNER MEDICATION AND WAS STRONGLY ADVISED TO CHECK INTO THE HOSPITAL FOR FURTHER EVALUATION BUT REFUSED. BOTH PATIENTS HAVE BEEN TREATED WITH FIRST AID MEASURES, CLEANING OF THE WOUND AND BANDAGES. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Abrasion

  MAUDE report 20154897 ↗
• InjuryJul 9, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SCANNER ON (B)(6) 2024. AN (B)(6) FEMALE PATIENT WITH MULTIPLE SCLEROSIS, AND IN AN ALTERED MENTAL STATUS, WAS POSITIONED ON THE SCANNING TABLE LAYING SUPINE AND HEADFIRST. AFTER THE SCAN WAS FINISHED, THE PATIENT'S RIGHT ARM DROPPED UNOBSERVED FROM THE TABLETOP AND BECAME WEDGED BETWEEN THE BOTTOM OF THE TABLETOP AND THE GANTRY BORE DURING THE TABLE UNLOAD MOVEMENT. ON (B)(6), 2024, IT WAS REPORTED THAT THE PATIENT SUFFERED AN AVULSION TO THE RIGHT FOREARM WHICH REQUIRED SURGERY AND SKIN GRAFT. AT THIS TIME, THE CURRENT HEALTH STATUS OF THE PATIENT IN UNKNOWN.

  Patient problems: Abrasion; Skin Tears

  MAUDE report 19700315 ↗
• MalfunctionMay 24, 2024Delayed Program or Algorithm Execution; Delayed Program or Algorithm Execution

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. ON (B)(6) 2024, THE SCAN OF A STROKE PATIENT WAS INTERRUPTED BY A COLLIMATOR ERROR. THE CUSTOMER WAITED FOR A GANTRY RESET AND WAS ABLE TO COMPLETE THE SCAN. AS A RESULT OF THE COLLIMATOR ERROR, THE SCAN WAS DELAYED FOR 2 MINUTES. NO NEGATIVE HEALTH CONSEQUENCE WAS REPORTED FOR THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392354 ↗
• MalfunctionMay 24, 2024Computer Software Problem; Delayed Program or Algorithm Execution; Computer Software Problem; Delayed Program or Algorithm Execution

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. ON (B)(6) 2024, THE CUSTOMER STATED THAT THE SCAN OF A STROKE PATIENT WAS NOT ABLE TO BE PERFORMED. THEREFORE, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR SCANNING. THE DELAY LASTED APPROXIMATELY 90 MINUTES. NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER AND NO NEGATIVE HEALTH CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392257 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING SCREENING OF CUSTOMER REPORTED ISSUES TO THE CHINESE AUTHORITY NMPA ON JANUARY 28, 2024, SIEMENS HEALTHINEERS BECAME AWARE THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. ON (B)(6) 2024, IT WAS REPORTED THAT AN UNCONSCIOUS PATIENT WAS POSITIONED ON THE CT TABLE WITH SUPPORT FROM THE PATIENT'S FAMILY MEMBERS AND ALSO BROUGHT BACK TO THE HOSPITAL BED AFTER THE SUCCESSFUL SCAN. THE PATENT¿S FAMILY NOTICED ABNORMALITIES AND INFORMED THE ATTENDING PHYSICIAN. EVALUATION DISCOVERED THE PATIENT HAD A FRACTURE TO HIS LEFT UPPER ARM. THE PATIENT WAS NOT AN EMERGENCY PATIENT, REGARDLESS THAT HE WAS UNCONSCIOUS. AS TO OUR KNOWLEDGE THE PATIENT IS CURRENTLY STILL HOSPITALIZED FOR TREATMENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 18721309 ↗
• InjuryFeb 6, 2024Adverse 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 DEFINITION AS CT SYSTEM. ON (B)(6) 2024, IMAGE RECONSTRUCTION FOR AN ADULT FEMALE EMERGENCY PATIENT TOOK VERY LONG. IT WAS REPORTED THAT THE PATIENT LATER DIED DUE TO HER SEVERE HEALTH CONDITIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18655804 ↗
• MalfunctionJan 16, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS SYSTEM. IT WAS REPORTED THAT A RADIOLOGY TECHNICIAN RECEIVED AN ELECTRIC SHOCK WHEN TRYING TO RESET THE F1- BREAKER IN THE POWER DISTRIBUTION CABINET (PDC) OF THE SYSTEM. THE RADIOLOGY TECHNICIAN DID NOT SUFFER ANY INJURIES AND WAS MEDICALLY EXAMINED ONSITE WITH NO NEGATIVE HEALTH FINDINGS. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Electric Shock

  MAUDE report 18516424 ↗
• MalfunctionSep 6, 2023Program or Algorithm Execution Problem; Delayed Program or Algorithm Execution; Program or Algorithm Execution Problem; Delayed Program or Algorithm Execution

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. ON (B)(6) 2023, A 14-YEAR-OLD FEMALE, POLYTRAUMA PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR A HEAD, SPINE, AND THORAX EXAMINATION. THE HEAD SCAN WAS COMPLETED SUCCESSFULLY, HOWEVER, DUE TO A TECHNICAL ISSUE, THE OPERATOR COULD NOT CONTINUE THE PLANNED SPINE AND THORAX EXAMINATIONS. THE CUSTOMER DECIDED TO TRANSFER THE PATIENT TO THE RADIOLOGY DEPARTMENT WHERE THE SPINE AND THORAX EXAMINATIONS COULD BE COMPLETED SUCCESSFULLY WITH A DELAY OF 20 MINUTES. IT WAS REPORTED THAT THE PATIENT PASSED AWAY APPROXIMATELY FIVE HOURS LATER. ACCORDING TO THE CUSTOMER, THE DELAY IN PROCEDURE DID NOT CAUSE NOR CONTRIBUTE TO THE PATIENT¿S DEATH. THE CUSTOMER CONFIRMED BY PHONE THAT THE PATIENT DEATH WAS DIRECTLY RELATED TO THE SERIOUS INJURIES CAUSED BY A TRAFFIC ACCIDENT. THIS REPORT IS SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689016 ↗
• 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 DEFINITION AS CT SYSTEM. FOLLOWING EXAMINATION, AN ELDERLY FEMALE PATIENT GRABBED THE SIDE OF THE TABLE DURING TABLE MOVEMENTS AND HER HAND WAS CLAMPED IN THE GAP BETWEEN THE TABLETOP AND SIDE COVER. THE PATIENT SUFFERED A MINOR SKIN INJURY TO THE HAND WHICH DID NOT REQUIRE MEDICAL INTERVENTION. WE ARE UNAWARE OF ANY FURTHER IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: Abrasion

  MAUDE report 17497583 ↗
• InjuryJul 19, 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 DEFINITION AS CT SYSTEM. ON (B)(6)2023, A FEMALE PATIENT , APPROXIMATELY 70 YEARS OLD WAS TO UNDERGO EXAMINATION. PRIOR TO SCANNING, THE PATIENT ADVISED THE STAFF THAT THERE WAS SOMETHING IN HER POCKET. THE STAFF INFORMED HER THAT IT WOULD NOT AFFECT THE SCAN OR DIAGNOSIS, HOWEVER, SHE STILL DECIDED TO GET OFF THE BED ON HER OWN TO REMOVE THE ITEM. WHEN THE PATIENT JUMPED DOWN FROM THE TABLE, SHE SUFFERED A FOOT FRACTURE. CURRENTLY, THE PATIENT IS RECEIVING TREATMENT WITH A PLASTER CAST, AND HER CONDITION IS STABLE. THE DEVICE IS NOT EXPERIENCING ANY MALFUNCTIONS.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 17350445 ↗
• MalfunctionApr 6, 2023Electrical /Electronic Property Problem; Arcing; Electrical /Electronic Property Problem; Arcing

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. ON (B)(6) 2023 A FAILURE WAS REPORTED DUE TO TUBE ARCING. AS A RESULT, A 12-YEAR-OLD MALE, WEIGHING APPROXIMATELY 110 POUNDS, WAS RESCANNED. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE CHILD ASSOCIATED WITH THE REPORTED EVENT. SIEMENS CONSIDERS CHILDREN AS A VULNERABLE PATIENT GROUP; THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688679 ↗
• MalfunctionFeb 7, 2023Failure to Analyze Signal; Device Sensing Problem; Failure to Analyze Signal; Device Sensing Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. A 58-YEAR-OLD MALE PATIENT, WEIGHING APPROXIMATELY 300 LBS, WAS POSITIONED ON THE CT TABLE FEET-FIRST. DURING THE SCAN, THE SYSTEM SHUT DOWN WHILE THE PATIENT WAS POSITIONED IN THE GANTRY. IT WAS REPORTED THAT THE PATIENT CRAWLED OUT OF THE GANTRY AND OFF THE TABLE BY HIMSELF. WHILE CRAWLING TOWARDS THE TABLE END, THE FOOTREST BROKE OFF THE TABLE AND THE PATIENT FELL WHILE SCRATCHING HIS BACK ON THE BROKEN PART OF THE FOOTREST. THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM AND NO FURTHER MEDICAL CARE WAS REQUIRED.

  Patient problems: Abrasion

  MAUDE report 16313317 ↗
• MalfunctionJan 23, 2023Mechanical Problem; Unintended Collision; Mechanical Problem; Unintended Collision

  SIEMENS HEALTHINEERS HAS BECOME AWARE OF A POTENTIAL RISK FOR PATIENT HEALTH WHEN USING THE SOMATOM DEFINITION AS CT SYSTEM. NO SUCH EVENT HAS OCCURRED AT THIS TIME. DURING SERVICE ACTIONS IT WAS RECOGNIZED THAT THE PHS (PATIENT HANDLING SYSTEM - PATIENT TABLE) AND THE GANTRY OF THE SCANNER MAY COLLIDE IF THE TABLE IS IN THE HIGHEST POSSIBLE POSITION AND THE GANTRY IS TILTED IN A POSITIVE DIRECTION BY UP TO +30 DEGREES. IF A PATIENT WOULD BE ON THE TABLE, POTENTIAL HARM CANNOT BE EXCLUDED. SIEMENS IS INVESTIGATING TO DETERMINE THE ROOT CAUSE FOR THIS BEHAVIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223346 ↗
• MalfunctionDec 19, 2022Output Problem; Radiation Output Failure; Output Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. SIEMENS WAS INFORMED ON NOVEMBER 21, 2022, VIA FDA MEDWATCH REPORT, THAT THE CT SCANNER ABORTED DURING A PATIENT SCAN ON (B)(6), 2022. ACCORDING TO THE INFORMATION AVAILABLE, THERE WERE NO INJURIES REPORTED. HOWEVER, IN THE WORST CASE, A RESCAN MIGHT BE NECESSARY AT A LATER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003947 ↗
• InjuryNov 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 DEFINITION AS CT SYSTEM. ON (B)(6), 2022, A TECHNOLOGIST RECEIVED AN ELECTRICAL SHOCK WHILE RESETTING A BREAKER. THE CUSTOMER FACILITY WAS CONDUCTING PROLONGED TESTING ON THEIR GENERATOR. EACH TIME THE POWER SWITCH-OVER OCCURRED, IT TRIPPED THE F1 BREAKER IN THE POWER DISTRIBUTION CABINET (PDC) OF THE CT SCANNER. THE CUSTOMER CONTACTED SIEMENS FOR ADVICE IN A SITUATION SUCH AS THIS AND WAS ADVISED TO PLACE A SERVICE CALL OR TO HAVE AN ELECTRICIAN OR CLINICAL ENGINEERING PERSONNEL TURN THE BREAKER BACK ON. AS THE FACILITY DID NOT WANT TO WAIT FOR A SIEMENS ENGINEER TO COME ONSITE NOR TO HAVE QUALIFIED PERSONAL RESET THE BREAKER, THE UNQUALIFIED TECHNOLOGIST WOULD RESET THE BREAKER WHEN NECESSARY. WHILE DOING SO, A TECHNOLOGIST BROKE THE BREAKER KNOB ON THE F1 BREAKER. THE FACILITY DID NOT PLACE A SERVICE CALL FOR REPAIR. THE GENERATOR TESTING CAUSED THE BREAKER TO TRIP AGAIN AND A TECHNOLOGIST ATTEMPTED TO USE THE BROKEN KNOB AS A KEY TO TURN THE BREAKER AND RECEIVED AN ELECTRICAL SHOCK BY THE KNOB. IT WAS CONFIRMED THAT THE TECHNOLOGIST DID NOT SUFFER ANY SERIOUS INJURY AND NO MEDICAL INTERVENTION

  Patient problems: Electric Shock

  MAUDE report 15851374 ↗
• MalfunctionSep 20, 2022Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. ON (B)(6), 2022, A 48 YEAR OLD MALE PATIENT CAME IN AS AN EMERGENCY PATIENT WITH A CEREBRAL HEMORRHAGE AND IN A COMA. THE PATIENT HANDLING SYSTEM (PHS - PATIENT TABLE) WAS LIFTING WITH THE PATIENT ON IT WHEN THE GANTRY POWERED OFF. IT WAS REPORTED THAT THIS CAUSED A DELAY IN DIAGNOSIS OF APPROXIMATELY 10 MINUTES. CURRENTLY THE PATIENT IS STILL IN THE INTENSIVE CARE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454736 ↗
• InjurySep 9, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION AS CT SYSTEM. ON (B)(6), 2022, A 1 YEAR OLD INFANT PATIENT UNDERWENT EXAMINATION. THE HEAD SPIRAL SCAN WAS ABORTED BECAUSE SOMEONE ACCIDENTALLY OPENED THE DOOR TO THE GANTRY ROOM AND THE DOOR SWITCH INTERRUPTED THE EXAMINATION. ACCORDING TO AVAILABLE INFORMATION, THE HEAD SPIRAL SCAN STOPPED AFTER 2.23 SECONDS FROM THE PLANNED 5.46 SECONDS AND THE EXAMINED PART COULD NOT BE RECONSTRUCTED. A RESCAN WAS NEEDED TO COMPLETE THE EXAMINATION. THERE WAS NO DELAY IN DIAGNOSIS AS THE CUSTOMER STARTED A SECOND SPIRAL SCAN IMMEDIATELY AFTER THE FIRST SCAN TO COMPLETE THE EXAMINATION. THE HEALTH STATUS OF THE INFANT IS WELL. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED IN ASSOCIATION WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392227 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130901, K190578, K230421. One submission often covers many models, so check the product and lot details in each record.

• Z-0472-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Confidence -Computed tomography systems Model 10590100
• 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-0289-2022 · Aug 30, 2021 · Terminated
  SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
• Z-0287-2022 · Aug 30, 2021 · Terminated
  SOMATOM Drive with software syngo.CT VB20 Model #10431700
• Z-0286-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
• Z-0284-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
• Z-0285-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
• Z-0288-2022 · Aug 30, 2021 · Terminated
  SOMATOM Confidence with software syngo.CT VB20 Model #10590100
• Z-0283-2022 · Aug 30, 2021 · Terminated
  SOMATOM Force with software syngo.CT VB20 Model #10742326
• 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
• Z-2270-2019 · Jul 3, 2019 · Terminated
  SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconst