System SOMATOM Confidence 10590100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869011011), received between Dec 30, 2020 and Oct 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).

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

13 other recalls cover devices cleared under the same FDA submission (K162302, 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.

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-0472-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM CONFIDENCE CT SCANNER LOCATED IN GERMANY. THE CUSTOMER REPORTED THE FOLLOWING SYSTEM BEHAVIOR: WHEN USING THE RT_RESP SCAN PROTOCOL IN COMBINATION WITH THE OPEN INTERFACE, THE RESPIRATORY CURVE IS IMPORTED INTO THE SYSTEM AFTER THE SCAN. SUBSEQUENTLY, IMAGE RECONSTRUCTION IS PERFORMED IN ¿AVERAGE¿ MODE AS WELL AS IN MULTIPHASE SERIES WITH PHASES RANGING FROM 0% TO 100% IN 10% INCREMENTS. IT WAS OBSERVED THAT, SPORADICALLY, THE SERIES DESCRIPTIONS AND THE IMAGE CONTENTS DO NOT MATCH. ALTHOUGH THE SERIES ARE LABELED WITH DIFFERENT PHASE IDENTIFIERS (E.G., 0%, 10%, 20%, ETC.), THE IMAGES SHOW IDENTICAL CONTENT, AND THE PATIENT¿S RESPIRATORY MOTION IS NOT VISIBLE. WHEN THE RECONSTRUCTION IS REPEATED, THE RESULTING IMAGES ARE CORRECT AND DISPLAY THE EXPECTED DIFFERENCES IN RESPIRATORY PHASES. THESE CT IMAGES ARE USED FOR RADIOTHERAPY PLANNING. IT CAN BE RULED OUT THAT THE IMAGES ARE USED DIRECTLY FOR TREATMENT DELIVERY, AS THEY ARE FIRST IMPORTED INTO AN EXTERNAL PLANNING SYSTEM. THE ACTUAL TREATMENT PLANNING IS THEN PERFORMED BY MEDICAL PHYSICISTS AND PHYSICIANS. DURING THIS STEP, THE DESCRIBED ISSUE (UN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377456 ↗
• MalfunctionDec 30, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED TO SIEMENS THAT THE GANTRY OF THE SOMATOM CONFIDENCE SYSTEM WAS SLIGHTLY TILTED BUT THE DISPLAY SHOWED AN UPRIGHT POSITION (0 DEGREES). THIS INCORRECT GANTRY POSITION WAS DOCUMENTED IN THE DICOM IMAGES AS WELL. SINCE THIS SYSTEM IS USED FOR RADIATION THERAPY (RT), THIS ISSUE IS A SAFETY CONCERN. CLARIFICATION FROM THE USER REPORTED THERE WAS NO INJURY TO THE PATIENT EXCEPT FOR SOME REPEATED PLANNING CT SCANS (EXACT NUMBER NOT PROVIDED). THE USER DID VISUALLY RECOGNIZE THE DEVIATION OF THE CT GANTRY POSITION ON THE SAME DATE (DECEMBER 04, 2020) BEFORE THE RT PLAN WAS CALCULATED. IF THE GANTRY POSITION AND DISPLAY DEVIATION ARE NOT RECOGNIZED BY THE USER, A TREATMENT PLAN COULD HAVE BEEN CREATED BASED ON THE IMAGES WITH THE INCORRECT GANTRY TILT ANGLE. THIS COULD RESULT IN TREATMENT DOSE TO THE WRONG LOCATION AND IN A WORST-CASE SCENARIO, MAY RESULT IN PATIENT INJURY. THE EXTENT OF THIS INCORRECT DOSE APPLICATION CANNOT BE QUANTIFIED, HOWEVER, SINCE IT IS DEPENDENT ON THE INDIVIDUAL TREATMENT PLAN FOR EACH PATIENT. AS OF THE DATE OF THIS REPORT, NO PATIENT INJURY RESULTING FROM THIS ISSUE HAS BEEN REPORTED TO SIEMENS. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095638 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162302, 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-0285-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
• Z-0289-2022 · Aug 30, 2021 · Terminated
  SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
• 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-0286-2022 · Aug 30, 2021 · Terminated
  SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
• Z-0283-2022 · Aug 30, 2021 · Terminated
  SOMATOM Force with software syngo.CT VB20 Model #10742326
• 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-2272-2019 · Jul 3, 2019 · Terminated
  SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstructio
• 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