System SOMATOM Definition Edge 10590000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04056869006949), received between Aug 12, 2020 and Aug 14, 2026 — classified as 1 death, 2 injuries, 8 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.

13 other recalls cover devices cleared under the same FDA submission (K143401, 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-0475-2022 · Root cause: Software Design Change · FDA record ↗

2. 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-0474-2022 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Intermittent Loss of Power; Unexpected Shutdown

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252880 ↗
• MalfunctionDec 12, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT AND MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM DEFINITION EDGE CT SYSTEM. ON (B)(6)2022, A SCAN WAS PERFORMED ON A PEDIATRIC MALE PATIENT. THE CUSTOMER REPORTED THAT THE USER INTERFACE OF THE SCANNER WAS NOT RESPONDING AFTER THE TOPOGRAM (LOW DOSE OVERVIEW SCAN). AS A RESULT, THE PATIENT WAS RESCANNED ON ANOTHER CT SYSTEM. BESIDE THE ADDITIONAL X-RAY DOSE, NO OTHER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959004 ↗
• DeathSep 8, 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 EDGE CT SYSTEM. ON (B)(6) 2022, AN 80-YEAR-OLD MALE TRAUMA PATIENT UNDERWENT A SCAN OF THE BRAIN, NECK, AND AREA FROM THE LUNGS TO THE PELVIS WITH CONTRAST MEDIA. THE SEQUENCES FOR THE BRAIN AND NECK WERE COMPLETED SUCCESSFULLY. DURING THE SCAN OF THE LUNGS TO THE PELVIS AREA, THE SCAN STOPPED JUST BEFORE SCANNING THE PELVIS. THE USER WAS ABLE TO CONTINUE THE PELVIS SCAN AFTER RESUMING THE CT SYSTEM. THERE WAS NO RESCAN OR ADDITIONAL CONTRAST MEDIA NEEDED. AT THE END OF THE EXAMINATION, THE USER RECOGNIZED THAT IT WAS NOT POSSIBLE TO RECONSTRUCT THE IMAGES OF THE LUNGS FOR DIAGNOSTICS. IT WAS REPORTED THAT THE PATIENT PASSED AWAY TWO HOURS LATER. ACCORDING TO OUR PRELIMINARY INVESTIGATION, THE RADIOLOGIST WAS ABLE TO SEE A CRANIAL INJURY AND NO ABNORMALITIES FOR THE ABDOMEN OR CHEST, BASED ON THE COLLECTED RAW DATA. THE PATIENT WAS NOT SCANNED AGAIN ON ANOTHER CT SYSTEM. THE CAUSE OF DEATH IS CURRENTLY NOT KNOWN BY THE MANUFACTURER. IT IS ALSO NOT CLEAR FROM THE ESCALATION DATA IF THE CT SCANNER HAS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. SIEMENS HAS REQUESTED ADDITIONAL INFORMATI

  Patient problems: Insufficient Information

  MAUDE report 15379470 ↗
• InjuryAug 3, 2022Improper or Incorrect Procedure or Method; Device Handling Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DEFINITION EDGE CT SYSTEM. A 90 YEAR OLD WOMAN SUFFERED A FRACTURE TO THE HUMERUS OF THE RIGHT ARM AFTER A WHOLE ABDOMEN EXAMINATION ON JULY 17, 2022. THE PATIENT WAS UNCONSCIOUS AT THE TIME OF THE EVENT AND WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION REGARDING THE PATIENTS HEALTH STATUS IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15156124 ↗
• MalfunctionMar 7, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS AFTER PERFORMING A POLYTRAUMA TOPOGRAM SCAN OF THE SKULL, THE USER INTERFACE OF THE CT SCANNER FROZE DURING THE POLYTRAUMA TOPOGRAM OF THE (B)(6)-YEAR-OLD PATIENT'S ABDOMEN AND PELVIS. THE PATIENT WAS THEN UNLOADED FROM THE REPORTED CT SCANNER AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT SCANNER. AFTER THE APPLICATION WAS RESTARTED, THE RECONSTRUCTIONS FROM THE FIRST SCAN RANGE (SKULL) FOR THIS PATIENT COULD BE PERFORMED. ASIDE FROM THE ADDITIONAL X-RAY DOSE FROM THE SECOND TOPOGRAM, NO PATIENT INJURY ASSOCIATED WITH EVENT WAS REPORTED TO SIEMENS. THE CHILD WAS IN GOOD MEDICAL CONDITION WHEN RELEASED. 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 13684011 ↗
• MalfunctionJun 28, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO SIEMENS THAT THE SCAN RANGE OF A (B)(6), MALE PATIENT WAS LONGER THAN EXPECTED. ASIDE FROM THE ADDITIONAL X-RAY DOSE, THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT. THIS REPORT HAS BEEN FILED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12079983 ↗
• MalfunctionFeb 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT DURING A PELVIMETRY CT EXAMINATION OF A (B)(6)-YEAR-OLD, PREGNANT WOMAN USING THE SOMATOM DEFINITION EDGE SYSTEM, AN ISSUE OCCURRED REQUIRING THE PATIENT TO BE RESCANNED. THE CUSTOMIZED SCAN PROTOCOL DID NOT INCLUDE A TOPOGRAM (LOW DOSE OVERVIEW IMAGE) AND FOLLOWING SPIRAL SCAN WAS PLANNED AND EXECUTED WITHOUT THE ASSISTANCE OF THE TOPOGRAM. THE PRIMARY FUNCTION OF A TOPOGRAM IS TO BE THE PLANNING BASE FOR THE SUBSEQUENT SPIRAL SCAN. AFTER THE SPIRAL SCAN WAS PERFORMED, THE OPERATOR REALIZED THAT THE ACQUISITION IMAGES DID NOT CONTAIN THE ENTIRE AREA OF INTEREST AND THE PATIENT HAD TO BE RESCANNED. ACCORDING TO THE PATIENT PROTOCOL, THE PATIENT WAS SCANNED THREE TIMES WITH A DOSE-LENGTH PRODUCT (DLP) OF 21MGY-CM FOR EACH SCAN RANGE, RESULTING IN A TOTAL DLP OF 63MGY-CM. THERE HAS BEEN NO REPORT OF PATIENT OR FETAL INJURY AS OF THE DATE OF THIS REPORT. 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 11363271 ↗
• MalfunctionDec 15, 2020Computer Software Problem; Computer Software Problem

  IT WAS REPORTED TO SIEMENS THAT DURING AN INTERVENTIONAL PROCEDURE OF AN (B)(6) YEAR- OLD FEMALE CHILD (BIOPSY PROCEDURE), THE SOFTWARE FROZE AND DID NOT RESPOND. AFTER THE SCANNER WAS RESTARTED SUCCESSFULLY, THE PROCEDURE WAS FINISHED BY SCANNING ONE ADDITIONAL TOPOGRAM (LOW DOSE OVERVIEW IMAGE), AND THREE LOW DOSE SPIRAL SCANS. NO OTHER INJURY HAS BEEN REPORTED TO US, EXCEPT THE X-RAY DOSE FROM THE ADDITIONAL CT SCANS. 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 11011875 ↗
• MalfunctionNov 10, 2020Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO SIEMENS THAT DURING A CONTRAST ENHANCED CT CHEST SCAN OF AN 11-DAY OLD INFANT PATIENT, BLURRY ARTIFACTS WERE OBSERVED ON THE CT IMAGE. THE INFANT WAS SEDATED AND INTUBATED DURING THE PROCEDURE. DUE TO THE SEVERE ARTIFACTS, A DIAGNOSIS WAS NOT POSSIBLE. AFTERWARDS, AN ULTRASOUND EXAMINATION WAS REQUIRED FOR THE DIAGNOSIS. THERE WERE NO NEGATIVE HEALTH CONSEQUENCES TO THE INFANT REPORTED TO SIEMENS WITH EXCEPTION OF THE X-RAY DOSE AND CONTRAST MEDIA ADMINISTERED WITHOUT CLINICAL BENEFIT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10818116 ↗
• MalfunctionSep 8, 2020Component Missing; Separation Problem; Component Missing; Separation Problem

  IT WAS REPORTED TO SIEMENS THAT DURING THE TABLE MOVEMENT OF THE SOMATOM DEFINITION EDGE NEXARIS SYSTEM (COMBINATION OF CT SCANNER AND ANGIO C-ARM), THE TABLETOP DISLOCATED FROM THE TABLE SUPPORT DUE TO MISSING SCREWS. AT THE TIME OF THE EVENT, A CT PHANTOM WAS PLACED ON THE TABLE AND THERE WAS NO PATIENT INVOLVEMENT. NO INJURY TO THE USER OR OTHERS WAS REPORTED. THE SYSTEM HAD BEEN RECENTLY INSTALLED AND THE SIEMENS APPLICATION SUPPORT SPECIALIST WAS ONSITE TO TRAIN THE CUSTOMER. THIS EVENT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10502866 ↗
• InjuryAug 12, 2020Break; Unintended Power Up; Premature Activation; Break; Unintended Power Up; Premature Activation

  IT WAS REPORTED TO SIEMENS THAT DURING A PATIENT INTERVENTIONAL PROCEDURE USING THE SOMATOM DEFINITION EDGE SYSTEM, A SINGLE SEQUENCE SCAN WAS RELEASED WITHOUT USER INITIATION. THIS EVENT WAS CAUSED BY A FOOT SWITCH (FOOT PEDAL) WITH A BROKEN CONNECTOR. IN TOTAL, FIVE PEOPLE WERE UNINTENTIONALLY EXPOSED TO THE ADDITIONAL X-RAY DOSE (SINGLE SEQUENCE SCAN WITH A DURATION OF 0.5 SECONDS). THE FIVE PEOPLE INCLUDED: THE PATIENT WHO WAS ON THE TREATMENT TABLE; A PHYSICIAN WHO WAS POSITIONED ADJACENT TO THE OPPOSITE SIDE OF THE SYSTEM GANTRY; ONE TECHNICIAN WHO WAS NEAR THE PHYSICIAN; ONE TECHNICIAN WHO WAS KNEELING IN FRONT OF THE GANTRY AND; A NURSE ANESTHETIST WHO WAS POSITIONED AT THE FOOT END OF THE TREATMENT TABLE. THE INCIDENT OCCURRED AT THE BEGINNING OF THE INTERVENTIONAL PROCEDURE. THE PHYSICIAN WANTED TO RELEASE THE SCAN WITH THE FOOT SWITCH, BUT IT WAS NOT CONNECTED. THEREFORE, ONE OF THE TECHNICIANS WENT INTO THE ROOM IN ORDER TO CONNECT THE FOOT SWITCH. AS SOON AS THE TECHNICIAN CONNECTED THE FOOT SWITCH TO THE SCANNER, A SINGLE SCAN WAS RELEASED. THERE WAS NO REPORTED INJURY TO ANY OF THE FIVE PEOPLE, EXCEPT FOR THE ADDITIONAL SINGLE SEQUENCE SCAN X-RAY DOSE. ADDITIONAL INF

  Patient problems: No Code Available

  MAUDE report 10395793 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143401, 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-0473-2022 · Nov 19, 2021 · Open, Classified
  SOMATOM Definition AS-Computed tomography system Model 8098027
• Z-0283-2022 · Aug 30, 2021 · Terminated
  SOMATOM Force with software syngo.CT VB20 Model #10742326
• Z-0285-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
• Z-0284-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
• Z-0288-2022 · Aug 30, 2021 · Terminated
  SOMATOM Confidence with software syngo.CT VB20 Model #10590100
• Z-0289-2022 · Aug 30, 2021 · Terminated
  SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
• Z-0286-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
• Z-0287-2022 · Aug 30, 2021 · Terminated
  SOMATOM Drive with software syngo.CT VB20 Model #10431700
• 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-2626-2016 · Jul 13, 2016 · Terminated
  SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
• Z-0019-2016 · Aug 14, 2015 · Terminated
  SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at diff