Somatom Force 10742326Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04056869006956), received between Oct 13, 2020 and May 8, 2026 — classified as 3 deaths, 7 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

22 other recalls cover devices cleared under the same FDA submission (K133589, 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. IT WAS REPORTED THAT A MEDICAL MONITOR FELL INTO THE GANTRY DURING PATIENT UNLOADING. THE IMPACT DESTROYED THE PLEXIGLAS RING ALLOWING THE MONITOR TO ENTER THE GANTRY, WHERE IT SUBSEQUENTLY DAMAGED THE X RAY TUBE COLLIMATOR. 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 25122362 ↗
• MalfunctionFeb 6, 2026Failure to Sense; Radiation Overexposure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. BASED ON THE INFORMATION AVAILABLE, A PERFUSION SCAN WAS ABORTED AND SUBSEQUENTLY HAD TO BE REPEATED. AS A RESULT, THE ACUTE STROKE PATIENT REQUIRED A SECOND SCAN AND A SECOND ADMINISTRATION OF CONTRAST MEDIUM. THE SCAN ABORT CAUSED A DELAY OF APPROXIMATELY 15 MINUTES IN ESTABLISHING THE DIAGNOSIS. NO INJURIES OR ADVERSE HEALTH EFFECTS HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276585 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. ACCORDING TO THE REPORT, AN OBESE PATIENT ¿CRAWLED¿ THROUGH THE GANTRY WHILE IT WAS ROTATING, CAUSING THE PLEXIGLASS RING TO BE PUSHED INTO THE GANTRY AND BREAK. 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 23801357 ↗
• MalfunctionNov 21, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SCANNER. THE PLEXIGLASS RING OF THE GANTRY WAS DISPLACED BY A CLAUSTROPHOBIC PATIENT. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. THIS INCIDENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615531 ↗
• MalfunctionMay 2, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. IT WAS REPORTED THAT AFTER AN 87-YEAR-OLD FEMALE PATIENT WAS POSITIONED ON THE TABLE AND PREPARED FOR CARDIO SCANS, THE SYSTEM HUNG UP AND WAS NOT ABLE TO START THE SCAN. THE OPERATOR HAD TO HARD RESET THE MACHINE TWICE. DURING THE SYSTEM RESET, THE PATIENT COLLAPSED, AND RESUSCITATION ATTEMPTS WERE INITIATED. EVEN THOUGH THE CARDIOLOGIST AND THE CARDIAC TEAM WERE PRESENT ON SITE, CPR WAS NOT SUCCESSFUL, AND THE PATIENT DIED. 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. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

  Patient problems: Cardiac Arrest

  MAUDE report 21949271 ↗
• InjuryJan 6, 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 FORCE CT SYSTEM. ON (B)(6) 2024, A 65-YEAR-OLD FEMALE HEMIPLEGIC PATIENT WAS PLANNED FOR A CT LUNG SCAN. IT IS REPORTED THAT THE PATIENT WAS ALREADY IN POOR CONDITION AND COULD NOT MOVE WELL. AFTER THE SCAN, WHILE MOVING THE PATIENT BACK INTO THE WHEELCHAIR, THE CUSTOMER CLAIMS THAT THE PATIENT WAS NOT OBSERVED WELL ENOUGH AND THAT PATIENT'S ARM BECAME STUCK, RESULTING IN A FRACTURE TO THE RIGHT UPPER LIMB. THE PATIENT WAS SENT TO THE ORTHOPEDIC DEPARTMENT FOR FURTHER TREATMENT AND WAS HOSPITALIZED. THE CURRENT PATIENT HEALTH STATUS IS REPORTED AS STABLE.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 21079136 ↗
• InjuryJul 26, 2024Improper 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 FORCE CT SYSTEM. ON (B)(6) 2024, A PATIENT LIFTED HIS LEG WHILE SCANNING AND BROKE THE SEALING RING (SCAN WINDOW). THE PATIENT SUFFERED A SMALL ABRASION ON HIS LEG. THE MINIMAL ABRASION DID NOT REQUIRE MEDICAL INTERVENTION AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: Abrasion

  MAUDE report 19840174 ↗
• InjuryJun 4, 2024Improper 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 FORCE CT SYSTEM. ON (B)(6) 2024, A THORAX AND ABDOMEN EXAMINATION WERE PERFORMED ON A 79-YEAR-OLD DISABLED FEMALE PATIENT. FOLLOWING THE SCAN, THE TECHNICIAN MOVED THE PATIENT OUT OF THE CT SYSTEM BY REGULAR UNLOADING PROCEDURE. NEITHER THE TECHNICIAN NOR FAMILY MEMBER WHO WAS IN ATTENDANCE RECOGNIZED THAT THE PATIENTS RIGHT ARM DROPPED FROM THE TABLE AND BECAME CAUGHT BETWEEN THE TABLETOP AND SUPPORT. AS A RESULT, THE PATIENT SUFFERED A FRACTURED HUMERUS AND BRUISING. THE PATIENT REQUIRED MEDICAL INTERVENTION; HOWEVER, IT WAS FURTHER REPORTED THAT THE PATIENT HAS DIABETES AND VERY HIGH BLOOD GLUCOSE, AND SURGERY WAS NOT POSSIBLE.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 19457386 ↗
• InjuryFeb 23, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. ON (B)(6) 2024, THE CUSTOMER REPORTED A LOUD NOISE AND OBSERVED THAT THE CT GANTRY SHIFTED IT¿S ORIGINAL POSITION. AS A RESULT, A PATIENT WAS INJURED. FURTHER INFORMATION REGARDING THE PATIENT'S HEALTH STATUS AND THE EXTENT OF INJURY IS NOT KNOWN AT THIS TIME. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THEREFORE, THIS REPORT IS SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 18766667 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. IT WAS REPORTED THAT TABLE MOVEMENTS CAUSED A PATIENT TO BECOME PINNED BETWEEN THE GANTRY AND TABLE. IT IS UNCLEAR AT THIS TIME IF THE PATIENT SUFFERED AN INJURY OR IF AN EMPLOYEE WAS INJURED, AND THE NATURE OF THAT INJURY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18490872 ↗
• MalfunctionMay 8, 2023Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. ON (B)(6) 2023, DURING A SCAN OF A 2-YEAR-OLD INFANT, THE EXAM WAS UNEXPECTEDLY ABORTED. THE INFANT RECEIVED ADDITIONAL DOSE DUE TO A NECESSARY RESCAN. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE INFANT ASSOCIATED WITH THE REPORTED EVENT. THEREFORE, THIS REPORT IS SUBMITTED WITH AN ABUNDANCE OF CAUTION AS SIEMENS CONSIDERS INFANTS AS A VULNERABLE PATIENT GROUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884824 ↗
• MalfunctionMar 20, 2023Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. DURING A SCAN OF A 7-MONTH OLD FEMALE PATIENT, THE EXAM WAS UNEXPECTEDLY ABORTED. AFTER A RESTART OF THE CT SYSTEM, THE USER WAS ABLE TO FINISH THE EXAMINATION. A REINJECTION WITH CONTRAST MEDIA AND RESCAN OF THE PATIENT WAS NECESSARY. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE INFANT ASSOCIATED WITH THE REPORTED EVENT. THEREFORE, THIS REPORT IS SUBMITTED WITH AN ABUNDANCE OF CAUTION AS SIEMENS CONSIDERS INFANTS AS A VULNERABLE PATIENT GROUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573766 ↗
• InjuryJan 23, 2023Image Display Error/Artifact; Output Problem; Image Display Error/Artifact; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION AND ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. SIEMENS WAS NOTIFIED THAT AN 11 YEAR OLD FEMALE PATIENT NEEDED TO BE RESCANNED DUE TO IMAGE RING ARTIFACTS. AS WE CONSIDER CHILDREN AS A VULNERABLE PATIENT GROUP, THIS REPORT IS FILED IN THE ABUNDANCE OF CAUTION. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223626 ↗
• InjuryDec 22, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED TO SIEMENS THAT A HEMIPLEGIC PATIENT WITH POOR CONTROL WAS INJURED DURING AN ABDOMINAL EXAMINATION USING THE SOMATOM FORCE SYSTEM. AFTER COMPLETION OF THE ABDOMEN SCAN THE OPERATOR MOVED THE PATIENT TABLE OUT OF THE GANTRY. DURING THE MOVEMENT OF THE PATIENT TABLE THE PATIENT´S LEFT ARM SLIPPED INTO THE GAP BETWEEN THE GANTRY AND THE PATIENT TABLE AND BECAME TRAPPED, RESULTING IN A HUMERAL FRACTURE. THE CUSTOMER ALLEGED THAT THE PATIENT TABLE MOVED QUICKLY, AND THE DIAMETER OF THE TABLE WAS TOO SMALL, RESULTING IN THE OPERATOR HAVING A BLIND SPOT. THE USER COULD NOT OBSERVE THE UPPER LIMBS OF THE PATIENT. THE PATIENT WAS NOT SECURED WITH AN IMMOBILIZATION STRAP TO AFFIX THE LIMBS AND BODY THE CUSTOMER IMMEDIATELY SENT THE PATIENT FOR ADDITIONAL DIAGNOSIS AND THE PATIENT'S ARM WAS TREATED WITH PLASTER CAST. THE PATIENT WAS IN STABLE CONDITION UNDER THE TREATMENT.

  Patient problems: Limb Fracture

  MAUDE report 16034312 ↗
• MalfunctionNov 28, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WITH THE SOMATOM FORCE SYSTEM. DURING AN EXAMINATION WITH A PEDIATRIC PATIENT, COMMUNICATION BETWEEN THE GANTRY AND THE IMAGE RECONSTRUCTION SYSTEM (IRS) WAS DISRUPTED. SIEMENS IS UNAWARE WHETHER THE PATIENT WAS RESCANNED FOLLOWING THE OCCURRENCE. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE PATIENT IN ASSOCIATION WITH THE REPORTED EVENT. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN CHINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870934 ↗
• MalfunctionJul 12, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT A CT SCAN USING THE SOMATOM FORCE SYSTEM ABORTED DURING A TURBO FLASH SPIRAL INVESTIGATION OF A ONE-YEAR-OLD PATIENT. THE USER DID NOT RESCAN THE PATIENT TO AVOID AN ADDITIONAL X-RAY DOSE AND RESCHEDULED THE PATIENT TO UNDERGO AN MRI (MAGNETIC RESONANCE IMAGING). THE PATIENT HAD BEEN SEDATED DURING THE SCANNING PROCEDURES. AFTER THE MRI SCAN, THE PATIENT WAS BROUGHT TO THE SURGERY ROOM. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE PATIENT IN ASSOCIATION WITH THE REPORTED EVENT. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN GERMANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986977 ↗
• MalfunctionJun 3, 2022Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. THE USER REPORTED THAT THE PHS (PATIENT TABLE) DID NOT MOVE TO THE SCANNING START POSITION AFTER A TOPO SCAN (LOW DOSE OVERVIEW SCAN). AS A RESULT, THE MALE PEDIATRIC PATIENT, WHO IS LESS THAN ONE YEAR IN AGE, WAS SCANNED AGAIN ON ANOTHER CT SYSTEM. IT WAS REPORTED THAT THE PATIENT IS IN GOOD HEALTH AND 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 14591568 ↗
• MalfunctionApr 29, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT THE CT SCANNER STOPPED MID-SCAN DURING THE EXAMINATION OF A (B)(6) FEMALE PATIENT. AN ERROR WAS DISPLAYED. THE CUSTOMER COULD NOT COMPLETE THE FULL SCAN AND THE SCAN HAD TO BE REPEATED. ASIDE FROM THE ADDITIONAL X-RAY DOSE ADMINISTERED TO THE PATIENT DURING THE SUCCESSFULLY COMPLETED SECOND SCAN, NO PATIENT INJURY HAS BEEN REPORTED TO SIEMENS. THIS REPORT HAS BEEN FILED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250179 ↗
• MalfunctionApr 27, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED TO SIEMENS THAT A NON- CONTRAST CT SCAN OF A (B)(6) PATIENT HAD TO BE REPEATED. A COMMUNICATION FAILURE SUDDENLY OCCURRED DURING THE DELAYED PHASE COUNTDOWN IN A MULTI-PHASE SCAN. ASIDE FROM THE ADDITIONAL X-RAY DOSE ADMINISTERED TO THE PATIENT DURING THE SUCCESSFULLY COMPLETED SECOND SCAN, NO PATIENT INJURY HAS BEEN REPORTED TO SIEMENS. 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 14219702 ↗
• MalfunctionMar 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO SIEMENS THAT THE BACKS OF THE (B)(6) PATIENT'S LEGS WERE ABRADED BY THE TABLE SIDERAIL WHILE THE PATIENT WAS GETTING OFF THE CT TABLE AFTER THE PROCEDURE. THE INJURY WAS INITIALLY REPORTED TO SIEMENS AS A LOSS OF SKIN AND BLEEDING. THE PATIENT WAS PROVIDED WITH FIRST AID AT THE TIME OF THE EVENT BY THE ATTENDING RADIOLOGIST AND NURSE. THE PATIENT WAS ADVISED TO FOLLOW-UP WITH HIS DOCTOR FOR ADDITIONAL EXAMINATION OF THE WOUNDS AND SUTURES, IF NECESSARY; HOWEVER, MEDICAL INTERVENTION WAS NOT IMMEDIATELY NEEDED. ACCORDING TO SUPPLEMENTAL INFORMATION PROVIDED TO SIEMENS ON (B)(6) 2022, THE MINOR INJURY WAS ATTRIBUTED TO THE PATIENT'S FRAGILE AND THINNING SKIN. IT WAS FURTHER REPORTED THE PATIENT'S WOUND AND HEALTH STATUS ARE GOOD.. THE SIEMENS FIELD SERVICE ENGINEER EXAMINED THE CT TABLE SIDERAILS AND CONFIRMED THERE WERE NO SHARP EDGES. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Abrasion

  MAUDE report 13838829 ↗
• MalfunctionDec 23, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT A (B)(6) CHILD NEEDED TO BE RE-SCANNED DUE TO A SOMATOM FORCE SOFTWARE FREEZE. AFTER THE FORCED SHUTDOWN AND RESTART, THE SCANNER WAS FULLY OPERATIONAL AGAIN AND THE PROCEDURE WAS COMPLETED. ASIDE FROM THE ADDITIONAL X-RAY DOSE FOR THE ADDITIONAL SCAN, NO NEGATIVE PATIENT HEALTH EFFECTS WERE REPORTED. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078303 ↗
• MalfunctionNov 29, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS THAT DURING THE HEAD SCAN OF A (B)(6) PATIENT, THE BABY MOVED DURING THE SCAN. THE OPERATOR PRESSED THE SUSPEND BUTTON TO STOP THE SCAN, THEN PERFORMED A SECOND SCAN WHICH WAS REPORTED TO GOOD. THE OPERATOR WAS UNABLE TO RECON THE FIRST SCAN AS THE SCAN WAS TOO SHORT. THERE WERE NOT ENOUGH ROTATIONS TO ACQUIRE RAW DATA FOR AN IMAGE RECONSTRUCTION. ACCORDING TO THE HOSPITAL "THE CHILD IS FINE AND SUFFERED NO ILL EFFECTS" FROM THE ADDITIONAL SCAN. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883423 ↗
• DeathNov 24, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OF THE SOMATOM FORCE SYSTEM OCCURRED DURING THE PERFORMANCE OF A CARDIAC SCAN ON A NEWBORN INFANT (1 DAY OLD). THE PRE-MONITORING & MONITORING SCANS WERE COMPLETED AND WHILE THE USER WAS OBSERVING THE DELAY PERIOD TO ALLOW THE CONTRAST TO BE ADMINISTERED FOR THE BOLUS MONITORING, THE SCAN DID NOT COMMENCE AND AS A RESULT, THE SYSTEM NEEDED TO BE RESTARTED. THE SCAN CONTINUED AFTER THE SYSTEM REBOOT, BUT THIS INADVERTENTLY CAUSED A DELAY RESULTING IN THE NECESSITY FOR ADDITIONAL CONTRAST TO BE ADMINISTERED. THE ONLY NEGATIVE IMPACT OF THIS EVENT WAS THE NECESSITY FOR ADDITIONAL CONTRAST MEDIA DUE TO THE DELAY CAUSED BY THE TIME NEEDED TO REBOOT THE SYSTEM. THE RADIOGRAPHER INDICATED THAT THERE WAS NO ADVERSE IMPACT TO THE PATIENT FROM THE ADDITIONAL CONTRAST. ACCORDING TO THE HOSPITAL, THE INFANT UNFORTUNATELY DIED DUE TO CARDIAC FAILURE ASSOCIATED WITH A BIRTH DEFECT. THE INFANT'S DEATH WAS NOT ASSOCIATED WITH THE REPORTED INCIDENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Cardiac Arrest

  MAUDE report 12870019 ↗
• DeathSep 30, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS THAT A (B)(6), FEMALE PATIENT WENT INTO CARDIAC ARREST DURING A CT EXAMINATION USING THE SOMATOM FORCE SYSTEM. THERE WAS INDECISION ON BEHALF OF THE CLINICAL TEAM PRESENT DURING THE EVENT REGARDING DEFIBRILLATION OF THE PATIENT WHO WAS STILL ON THE CT TABLE. FACILITY STAFF CONTACTED THE SIEMENS SERVICE CENTER FOR ASSISTANCE WHILE THE PATIENT'S HEALTH STATUS WAS CRITICALLY DECLINING. THE PATIENT HAS SINCE EXPIRED. ADDITIONAL DETAILS REGARDING THE EVENT WERE NOT REPORTED TO SIEMENS. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Cardiac Arrest

  MAUDE report 12553761 ↗
• MalfunctionJun 15, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. ON (B)(6) 2021, A (B)(6)-MONTH-OLD FEMALE PATIENT WAS SCANNED ON THE SOMATOM FORCE CT SCANNER. DURING THE CRANIAL CT SCAN, THE PATIENT MOVED, AND THE SCAN DID NOT COVER THE REQUIRED ANATOMICAL STRUCTURE. A SHORT SCAN NEEDED TO BE REPEATED, HOWEVER, THE SECOND SCAN WAS SUSPENDED BY THE USER WHICH RESULTED IN THE SCAN BEING TECHNICALLY TOO SHORT FOR RECONSTRUCTION AS THE SCAN LENGTH WAS SMALLER THAN ONE PHYSICAL DETECTOR WIDTH. THE CHILD WAS NOT SCANNED A THIRD TIME. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11997830 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133589, 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-0472-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Confidence -Computed tomography systems Model 10590100
• Z-0473-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Definition AS-Computed tomography system Model 8098027
• 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-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-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-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 7 more.