SOMATOM Definition Flash 10430603Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04056869006963), received between Jul 22, 2020 and Apr 28, 2026 — classified as 1 death, 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 reports).

18 other recalls cover devices cleared under the same FDA submission (K143416, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. DURING THE EXAMINATION, THE PATIENT PRESSED HIS KNEE AGAINST THE PLEXIGLASS RING AND CAME INTO CONTACT WITH MOVING PARTS OF THE SYSTEM. AS A RESULT, THE PATIENT SUSTAINED A MINOR SUPERFICIAL LACERATION TO THE KNEE. THE INJURY DID NOT INVOLVE DEEPER STRUCTURES SUCH AS LIGAMENTS OR BONE. THE PATIENT RECEIVED MEDICAL TREATMENT AT THE HOSPITAL, WHERE SUTURES WERE APPLIED TO CLOSE THE WOUND.

  Patient problems: Laceration(s)

  MAUDE report 25014210 ↗
• MalfunctionApr 8, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. AN INCIDENT OCCURRED DURING PATIENT UNLOADING WHILE USING AN ADAPTABLE HEAD ARM SUPPORT ACCESSORY. DURING TABLE RETRACTION AND DOWNWARD MOVEMENT, THE HEAD ARM SUPPORT BECAME DISPLACED AND CAME INTO CONTACT WITH THE GANTRY WINDOW STRIP, RESULTING IN MECHANICAL DAMAGE TO THE WINDOW STRIP. AS A PRECAUTIONARY MEASURE, THE SYSTEM WAS TAKEN OUT OF SERVICE. NO INJURIES TO THE PATIENT OR PERSONNEL WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815995 ↗
• MalfunctionAug 18, 2025Output Problem; Radiation Output Failure; Output Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SCANNER. THE CUSTOMER ATTEMPTED TO PERFORM A HEAD SPIRAL CT SCAN ON A PATIENT WITH A SUSPECTED STROKE. THE SCAN WAS ABORTED THREE TIMES, AND THE PATIENT WAS SUBSEQUENTLY SCANNED ON A DIFFERENT CT SYSTEM. NO STROKE WAS DETECTED; HOWEVER, IT WAS REPORTED THAT THE REPEATED SCAN ABORTS RESULTED IN A DIAGNOSTIC DELAY OF APPROXIMATELY 25 MINUTES. 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 22825690 ↗
• MalfunctionMar 28, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. THE USER REPORTED A PROBLEM WITH THE CT-SCAN OF TWO PATIENTS. THE FIRST PATIENT, A 72-YEAR-OLD MAN, 100 KG, WAS EXAMINED ON SUSPICION OF AN AORTIC DISSECTION. THE SCAN ABORTED TWICE AND WAS SUCCESSFULLY COMPLETED ON THE THIRD TRY. THE DELAY IN DIAGNOSIS WAS APPROXIMATELY 26 MINUTES. BESIDE THE ADDITIONAL RADIATION DOSE, NO NEGATIVE HEALTH CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED BECAUSE OF THIS DELAY. THE SECOND PATIENT, A 34-YEAR-OLD WOMAN, 110 KG, WAS EXAMINED BECAUSE OF A SUSPECTED STROKE. THE SCAN ABORTED AND THE CUSTOMER FINISHED THE DIAGNOSIS ON AN MRI-SYSTEM. ACCORDING TO THE CUSTOMER, THE DELAY IN DIAGNOSIS WAS 30 MINUTES. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE PATIENT CAUSED BY THIS DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717553 ↗
• InjuryNov 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT AN INJURY TO A PATIENT OCCURRED ON (B)(6) 2024 WHILE USING THE SOMATOM DEFINITION FLASH IN BRAZIL. THE PATIENT WAS SCHEDULED FOR A CHEST CT, ABDOMEN CT AND A SINUSES CT. AT SOME POINT DURING ONE OF THOSE EXAMS THE PATIENT HIT HER LEFT HAND ON A PART OF THE PATIENT HANDLING SYSTEM (PHS) WHICH WAS UNCOVERED AND CUT HER FOURTH FINGER. IT IS UNCLEAR IF THIS HAPPENED PRIOR TO THE PATIENT RECEIVING ANY RADIATION OR NOT. THE PATIENT INJURY WAS TREATED BY LOCAL PHYSICIANS AND AN X-RAY OF HER HAND WAS NECESSARY. PATIENT RECEIVED THREE STICHES ON HER FOURTH FINGER OF THE LEFT HAND AND AN ADMINISTERED A HIGH DOSE OF AN UNSPECIFIC ANTIBIOTIC. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER TWO DAYS OF THE INCIDENT, BUT IT IS UNCLEAR IF THE STAY WAS CAUSED BY THE INJURY OR BY AFTER CARE FOR THE TRANSPLANT.

  Patient problems: Abrasion

  MAUDE report 20787126 ↗
• MalfunctionSep 18, 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 A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. THE USER REPORTED THAT DURING AN EXAMINATION ON (B)(6) 2024, THE SEALING RING IN THE MIDDLE OF THE GANTRY WAS DAMAGED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245145 ↗
• MalfunctionMar 1, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. ON (B)(6), 2024, WHILE SCANNING A PATIENT, THE CUSTOMER HAD EXCESS BLANKETS ON THE TABLE AT THE HEAD END. WHEN BRINGING THE PATIENT OUT OF THE GANTRY, THE BLANKETS SLIPPED FROM THE PATIENT HANDLING SYSTEM (PHS) AND ONTO THE PLEXI RING. THE MOVING TABLE THEN PUSHED THE STACKED SHEETS INTO THE PLEXI RING. THE BLANKETS BECAME CAUGHT IN THE ROTATING PART OF THE GANTRY, PULLING THE ECG MONITOR INTO THE PLEXI RING AND ULTIMATELY BREAKING IT. THE PATIENT WAS SAFELY REMOVED FROM THE SYSTEM AND THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815736 ↗
• InjurySep 8, 2023Use of Device Problem; Use of Device Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH SYSTEM. PATIENT´S RIGHT HAND WAS STUCK IN THE GAP BETWEEN THE TABLETOP AND THE TABLE SIDE COVER DURING UNLOADING THE PATIENT HANDLING SYSTEM (PHS); THIS RESULTED IN AN INJURY TO THE PATIENT¿S FINGER. THE PATIENT´S FINGER WAS CLEANED AND BANDAGED. NO FURTHER MEDICAL TREATMENT WAS REQUIRED. SIEMENS SERVICE ENGINEER CHECKED THE INVOLVED HARDWARE, AND NO IRREGULARITIES WERE OBSERVED ON THE PHS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17711874 ↗
• InjuryAug 10, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. DURING A SCAN OF A 4-YEAR-OLD FEMALE PATIENT, THE OPERATOR REPORTED ARTIFACTS ON THE HEAD IMAGES. AS A RESULT, THE CLINICAL STAFF MADE THE DECISION TO CONDUCT A RESCAN OF THE PATIENT. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE CHILD ASSOCIATED WITH THE REPORTED EVENT. THEREFORE, THIS REPORT IS SUBMITTED WITH AN ABUNDANCE OF CAUTION AS SIEMENS CONSIDERS CHILDREN AS A VULNERABLE PATIENT GROUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497603 ↗
• InjuryJun 5, 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 FLASH CT SYSTEM. ON (B)(6) 2023, A PATIENT WAS EXAMINED ON THE CT SYSTEM. AFTER THE EXAMINATION, WHEN THE PATIENT WAS BEING UNLOADED FROM THE GANTRY, THE PATIENTS FINGER WAS PINCHED AT THE PHS (PATIENT HANDLING SYSTEM- PATIENT TABLE). BASED ON AVAILABLE INFORMATION, A SKIN ABRASION WAS REPORTED AND THERE WAS NO REPORT OF A BROKEN BONE. THE PATIENT WAS SENT TO A HOSPITAL FOR FURTHER TREATMENT; HOWEVER, THE SEVERITY OF THE PATIENTS' INJURY AND WHAT TREATMENT WAS PROVIDED IS UNKNOWN AS THE HOSPITAL REFUSED TO SHARE FURTHER DETAILS. THEREFORE, THIS REPORT IS SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 17058256 ↗
• MalfunctionApr 6, 2023No Device Output; Output Problem; No Device Output; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. ON (B)(6) 2023 A 7-MONTH-OLD CHILD (MALE, 9 KG) WAS SCHEDULED FOR A HEART SCAN TO PLAN A SURGERY OF THE AORTIC ARCH. THE SCANNER DID NOT START AFTER TOPO AND 20 ML CONTRAST MEDIA WAS INJECTED. A SECOND SCAN WAS MADE WITH AN ADDITIONAL 8 ML OF CONTRAST MEDIA. ACCORDING TO THE HOSPITAL, THE SECOND CONTRAST MEDIA CALCULATION WAS NOT EXACT, AND THE IMAGES COULD ALSO NOT BE USED FOR DIAGNOSIS. THE HOSPITAL CONFIRMED THAT A THIRD SCAN WAS CONDUCTED ON (B)(6) 2023. THE PATIENT WAS TRANSFERRED FROM A NEIGHBORING HOSPITAL AND THERE IS CURRENTLY NO INFORMATION AVAILABLE REGARDING THE HEALTH STATUS OF THE PATIENT. 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 16688678 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED WHILE PERFORMING MAINTENANCE ACTIVITIES ASSOCIATED WITH A SOMATOM DEFINITION FLASH CT SYSTEM. A SIEMENS ENGINEER INJURED HIMSELF WHILE LIFTING A CRATE CONTAINING A SPARE PART (SLIP RING) TOGETHER WITH TWO COLLEAGUES ON (B)(6) 2022. THE SERVICE ENGINEER STATED THAT HIS ELBOW CRACKED SEVERAL TIMES AND HE LOST STRENGTH IN HIS ARM. THE ENGINEER ALSO REPORTED PAIN AND BRUISING. AN X-RAY AND MRI EXAMINATION WERE ORDERED FOR THE SERVICE ENGINEER. THE X-RAY EXAMINATION WAS PERFORMED. FURTHER INFORMATION ON THE EXTENT OF THE INJURY HAS BEEN REQUESTED BUT ARE NOT KNOWN AT THE TIME OF REPORTING.

  Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy

  MAUDE report 15851373 ↗
• MalfunctionNov 11, 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 DEFINITION FLASH CT SYSTEM. IT WAS REPORTED THAT A PATIENT DIED ON (B)(6) 2022, ONE DAY AFTER AN EMERGENCY SCAN. THE PATIENT OF UNKNOWN AGE AND GENDER WAS EVALUATED ON (B)(6) 2022, FOR A HEAD AND COMBINED CHEST AND ABDOMEN SCAN. AFTER THE HEAD SCAN WAS COMPLETED AND THE TOPOGRAM FOR THE SECOND SCAN WAS COMPLETED, THE SPIRAL SCAN FOR THE CHEST AND ABDOMEN FAILED DUE TO A SYSTEM SCAN ABORT. ACCORDING TO OUR KNOWLEDGE, THE ABORTED SCAN WAS NOT REPEATED. THE PATIENT WAS TRANSFERRED FOR FURTHER EMERGENCY TREATMENT; HOWEVER, IT WAS REPORTED THAT THE PATIENT DIED ON THE NEXT DAY. CURRENTLY IT IS UNCLEAR IF THE CT SCANNER CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Cardiac Arrest

  MAUDE report 15780211 ↗
• InjurySep 9, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED PRIOR TO OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. ON (B)(6) 2002, TWO CHILDREN (15 MONTHS AND 7 YEARS) WERE PLANNED FOR EXAMINATION. A SYSTEM MALFUNCTION OCCURRED AND THE EXAMINATION COULD NOT BE PERFORMED. THE SIEMENS SERVICE ENGINEER CHECKED THE SYSTEM ONSITE AND FOUND TWO DEFECTIVE FUSES ON THE PDR COMPONENT (POWER DISTRIBUTION ROTATING) AND REPLACED THEM. FURTHER CHECKS WERE PERFORMED, AND A DEFECTIVE TUBE WAS ALSO IDENTIFIED. THE TUBE WAS REPLACED ON (B)(6) 2022, AND THE SYSTEM WAS BROUGHT BACK TO CLINICAL OPERATION. ACCORDING TO INFORMATION RECEIVED, BOTH PATIENTS WERE RESCANNED AND ARE IN GOOD HEALTH CONDITION. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE CHILDREN ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392235 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. ON (B)(6), 2022 A 6 MONTH OLD CHILD WAS PLANNED FOR A PROCEDURE WHEN THE GANTRY UNEXPECTEDLY SHUT DOWN. ACCORDING TO THE AVAILABLE INFORMATION, THE COMMUNICATION BETWEEN THE IMAGE RECONSTRUCTION SYSTEM (IRS) AND THE IMAGE CONTROL SYSTEM (ICS) WAS DISTURBED DUE TO A NETWORK ERROR. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE CHILD IN ASSOCIATION WITH THE EVENT AND A RESCAN WAS NOT CONDUCTED. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292443 ↗
• MalfunctionJul 18, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION FLASH CT SYSTEM. IT WAS REPORTED TO SIEMENS THAT A CHILD (1 YEAR OLD) WAS RESCANNED ON (B)(6) 2022. ACCORDING TO AVAILABLE INFORMATION, THE CUSTOMER PRESSED THE HOLD BUTTON AFTER THE TOPO SCAN (LOW DOSE OVERVIEW SCAN) AND ERROR MESSAGES WERE DISPLAYED. THE CUSTOMER RESOLVED THE ISSUE BY RESTARTING THE CT SYSTEM. THE SCAN OF THE CHILD COULD THEN BE COMPLETED. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE CHILD IN ASSOCIATION WITH THE REPORTED EVENT. NECESSARY DATA FOR A DETAILED TECHNICAL INVESTIGATION WAS REQUESTED, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, NO GENERAL PRODUCT ISSUE COULD BE IDENTIFIED AND THE ISSUE IS RATED AS A SINGLE OCCURRENCE. THIS REPORT HAS BEEN SUBMITTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041986 ↗
• MalfunctionJan 31, 2022Unintended Collision; Unintended Collision

  IT WAS REPORTED TO SIEMENS THAT DURING A PATIENT PROCEDURE, THE TABLETOP OF THE PHS (PATIENT HANDLING SYSTEM) TOUCHED THE CT GANTRY COVER WHILE PRESSING THE UNLOAD BUTTON. NEITHER THE PATIENT NOR THE USER WAS INJURED DURING THE EVENT. ACCORDING TO THE SIEMENS R&D EXPERT, IN A WORST-CASE SCENARIO, A CRUSHING-TYPE INJURY TO THE PATIENT OR USER CANNOT BE EXCLUDED IN THE CASE OF A RE-OCCURRENCE. THE COLLISION DETECTION SYSTEM DID NOT STOP THE TABLE MOTION BEFORE THE COLLISION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13391677 ↗
• MalfunctionOct 1, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT AN INFANT PATIENT HAD TO UNDERGO A SECOND TOPOGRAM SCAN (LOW DOSE OVERVIEW SCAN) DUE TO A SYSTEM MALFUNCTION DURING THE USE OF THE REPORTED SOMATOM DEFINITION FLASH SYSTEM. ASIDE FROM THE ADDITIONAL X-RAY DOSE, THERE WAS NO REPORT OF ADVERSE EVENT OR INJURY SUSTAINED BY THE PATIENT DUE TO THE NECESSITY OF THE SECOND SCAN. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561696 ↗
• InjuryJul 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AFTER A HEAD EXAMINATION OF A PATIENT USING THE SOMATOM DEFINITION FLASH SYSTEM, THE PATIENT'S ARM WAS FRACTURED IN A COLLISION DURING PATIENT TABLE UNLOADING (PHS MOVE-OUT). IT WAS FURTHER REPORTED THAT THE PATIENT'S ARMS WERE NOT FIXATED DURING THE EXAMINATION. THE PATIENT'S ARM FRACTURE WAS TREATED AT THE FACILITY, BUT ADDITIONAL INFORMATION WAS NOT MADE AVAILABLE TO SIEMENS. THIS REPORT HAS BEEN FILED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Limb Fracture

  MAUDE report 12143461 ↗
• MalfunctionApr 23, 2021Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO SIEMENS THAT CT BRAIN IMAGES OF A 2-YEAR-OLD PATIENT WERE TOO DARK TO USE. THE PATIENT HAD BEEN BROUGHT TO THE FACILITY EMERGENCY ROOM DUE TO LETHARGY. THE SIEMENS APPLICATION SPECIALIST CONTACTED THE USER BUT COULD NOT IDENTIFY A GENERAL ISSUE. WITH A SECOND RECONSTRUCTION THE IMAGE QUALITY WAS BETTER, BUT THE USER DECIDED TO PERFORM A SECOND SCAN USING A DIFFERENT CT SCANNER. THE PATIENT WAS ASLEEP DURING BOTH PROCEDURES. ASIDE FROM THE ADDITIONAL X-RAY DOSE, NO INJURY TO THE PATIENT WAS REPORTED TO SIEMENS. THIS REPORT WAS SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715614 ↗
• DeathDec 22, 2020Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED TO SIEMENS ON (B)(6) 2020 THAT A PATIENT EXPIRED AFTER A CT EXAMINATION ON (B)(6) 2020. THERE WAS A MALFUNCTION OF SOMATOM DEFINITION FLASH SCANNER WHICH CAUSED AN APPROXIMATE 20-MINUTE DELAY IN DIAGNOSIS. IT WAS NECESSARY TO REBOOT THE SYSTEM TWICE UNTIL IT WAS READY TO SCAN AGAIN. THE EXAMINATION WAS COMPLETED AFTER THE 20-MINUTE DELAY. THE SYSTEM LOG SHOWED THE FOLLOWING ERROR: "ROTATION MOTOR POSITION TIMEOUT." IT IS NOT CLEAR AT THIS TIME IF THE DELAY IN DIAGNOSIS CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. ADDITIONAL INFORMATION FROM THE REPORTING FACILITY IS PENDING. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Death

  MAUDE report 11057920 ↗
• MalfunctionDec 8, 2020Computer Software Problem; Computer Software Problem

  SIEMENS HAS IDENTIFIED THAT IN VERY RARE CASES (ONLY ONE SINGLE OCCURRENCE WORLDWIDE HAS BEEN REPORTED TO DATE) THE X-RAY DOSE IS INCORRECTLY RECORDED AS A NEGATIVE VALUE. SOMATOM FLASH AND DRIVE CT SYSTEMS WITH VB10A AND LATER VERSIONS ARE POTENTIALLY AFFECTED. THE FOLLOWING CONDITIONS MUST BE FULFILLED TO REPRODUCE THIS ISSUE: IF THE FILTER "MLMOVEABLEFILTER2BODYWEDGE" IS USED IN A SPIRAL SCAN AND THIS SCAN IS COMBINED WITH OTHER SCANS IN A WORKFLOW (CHRONICAL) AND THE OPTION "CARE KV GROUPING" IS SET TO "ON", OUR SYSTEM COPIES INTERNALLY PARAMETERS FROM ONE SPIRAL INTO THE OTHER SPIRALS. IF THERE ARE SPIRALS WITHOUT USING THIS FILTER, THE SYSTEM DETECTS THIS AS AN ERROR AND MARKS THE COPIED CTDI VALUE IN THE SECOND SPIRAL WITH A NEGATIVE SIGN. AFTERWARDS THE SUM FOR THIS CALCULATION IS NOT CORRECT/RESULTS IN A NEGATIVE CTDI. THERE HAS BEEN NO INCIDENT OF PATIENT INJURY OR OTHER ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968091 ↗
• MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL EVENT INFORMATION AND CLARIFICATION: ADDITIONAL INFORMATION FROM THE FACILITY REPORTED THAT AN ASSISTING PERSON, NOT THE PATIENT, WHO WAS SLIGHTLY INJURED DURING THE REPORTED EVENT. THE INJURED ASSISTANT WAS OFFERED MEDICAL TREATMENT BUT DECLINED. THE PATIENT'S ASSISTANT WAS HELPING THE PATIENT OFF THE TABLE TO A STRETCHER AND THE STRETCHER WAS CAUGHT UNDER THE TABLE AS THE TABLE WAS BEING LOWERED, CAUSING THE SIDE RAIL OF THE TABLE TO BREAK OFF. THE SIDE RAIL FELL ONTO THE ASSISTANT'S FOOT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10683118 ↗
• MalfunctionOct 12, 2020Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT PRIOR TO A CT CHEST EXAMINATION WITH THE SOMATOM DEFINITION FLASH SYSTEM, THE PATIENT, WHOSE HEALTH WAS DESCRIBED AS UNSTABLE AT THE TIME OF THE EXAMINATION AND WHOSE LEGS HAD BEEN AMPUTATED BELOW THE KNEE (DATE UNKNOWN), WAS POSITIONED ON THE PATIENT TABLE WITH THE LEGS POSITIONED IN A NEARLY VERTICAL POSITION. THIS WAS DUE TO THE PATIENT'S LEGS HAVING STIFFENED AND BEING SEVERELY CONTRACTED (PATIENT WAS UNABLE TO BE POSITIONED WITH LEGS HORIZONTAL TO THE PATIENT TABLE). IT WAS ALSO REPORTED THAT THE PATIENT HAD A STEEL PROSTHETIC OR PROSTHETICS ON ONE OR BOTH OF HIS LEGS AT THE TIME OF THE EXAM. DESPITE THE USER HAVING REPORTEDLY CHECKED THE PATIENT'S LEG POSITION FOR GANTRY CLEARANCE, THE PATIENT'S LEG PROSTHETIC(S) COLLIDED WITH THE GANTRY DURING TABLE MOVEMENT AT THE END OF THE CT SCAN. THIS RESULTED IN A BROKEN GANTRY COVER AND PLEXI-RING. THE PATIENT SUSTAINED MILD ABRASION INJURY TO THE KNEE(S). ACCORDING TO THE REPORT NO ADDITIONAL INJURIES WERE SUSTAINED ASIDE FROM THE MILD ABRASIONS. THE CT SCAN WAS COMPLETED. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Abrasion

  MAUDE report 10663140 ↗
• MalfunctionSep 9, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT DURING A CONTRAST ENHANCED CT SCAN OF A (B)(6)-MONTH OLD INFANT WITH THE SOMATOM DEFINITION FLASH SYSTEM, THE SCAN ABORTED IN THE MIDDLE OF THE SCAN. THE PARENT WAS STANDING NEXT TO THE GANTRY DURING THE EXAMINATION, WHEN THIS ISSUE OCCURRED. AFTER A REBOOT OF THE SCANNER, THE EXAMINATION COULD BE CONTINUED. CONSEQUENTLY, THE CHILD WAS RESCANNED, AND ADDITIONAL 7 ML OF CONTRAST MEDIA WAS GIVEN. AFTER THE CT EXAMINATION, A 4-HOUR SALINE DRIP NEEDED TO BE GIVEN TO THE PATIENT IN ORDER TO FLUSH CONTRAST. NO OTHER INJURY OF THE PATIENT HAS BEEN REPORTED EXCEPT THE ADDITIONAL XRAY DOSE, CONTRAST MEDIA AND NEED FOR THE SALINE DRIP. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10507425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143416, K190578, K230421. One submission often covers many models, so check the product and lot details in each record.

• Z-0473-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Definition AS-Computed tomography system Model 8098027
• 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-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-0287-2022 · Aug 30, 2021 · Terminated
  SOMATOM Drive with software syngo.CT VB20 Model #10431700
• 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-0283-2022 · Aug 30, 2021 · Terminated
  SOMATOM Force with software syngo.CT VB20 Model #10742326
• Z-0288-2022 · Aug 30, 2021 · Terminated
  SOMATOM Confidence with software syngo.CT VB20 Model #10590100
• 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
• Z-0743-2017 · Nov 15, 2016 · Terminated
  SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from eithe
• Z-0608-2017 · Nov 2, 2016 · Terminated
  SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body b

…and 3 more.