NAEOTOM Alpha 11330003Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056869263168), received between Jul 28, 2022 and Jul 23, 2024 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K211591, K220814, K233657, K243523, K251061); 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 18, 2026.

Recalls naming this device

1. Dec 19, 2025Class IIOpen, Classified

   To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

   Z-1240-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 22, 2022Class IIOpen, Classified

   In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

   Z-1003-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Image Display Error/Artifact; Output Problem; Image Display Error/Artifact; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE NAEOTOM ALPHA CT SCANNER IN THE UNITED STATES ON (B)(6) 2024. AFTER A SUCCESSFUL CT HEAD SCAN OF A STROKE PATIENT, THE READING RADIOLOGIST IDENTIFIED A LESION INFERIOR TO THE HEMORRHAGE. A SHORT TIME LATER, THE PATIENT¿S CONDITION DECLINED, AND A SUBSEQUENT CT WAS OBTAINED ON A DIFFERENT SCANNER. COMPARISON REVEALED THAT THE ORIGINAL OBSERVATION FROM THE NAEOTOM ALPHA SYSTEM WAS AN ARTIFACT AND NOT A LESION. AS PER OUR UNDERSTANDING, THERE WAS A DIAGNOSIS SCAN FOR STROKE TREATMENT DURING WHICH AN ADDITIONAL LESION WAS SEEN IN RECONSTRUCTED VNC (VIRTUAL NON CONTRAST) IMAGES, PRESUMABLY AS A CHANCE FINDING. THE SECOND SCAN BECAME NECESSARY DUE TO THE PATIENTS¿ HEALTH SITUATION. WHEN COMPARING THE IMAGES, THE CUSTOMER IDENTIFIED THE PREVIOUSLY SEEN LESION AS AN ARTIFACT. BASED ON OUR INVESTIGATION TO DATE, IT IS OUR UNDERSTANDING THAT THERE IS NO CONNECTION BETWEEN THE MENTIONED LESION AND THE REPORTED STROKE, BUT THE EXACT RELEVANCE FOR THIS CLINICAL CASE IS STILL UNCLEAR. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN AT THIS TIME. SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS WE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806732 ↗
• 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 NAEOTOM ALPHA CT SYSTEM. A 60-69-YEAR-OLD FEMALE PATIENT WAS PLANNED FOR TWO SCANS (HEAD AND THORAX/ABDOMEN). THE PATIENT WAS POSITIONED WITH FEET FIRST AND WAS INSTRUCTED BY THE OPERATOR TO HAVE BOTH ARMS CROSSED OVER THE BODY. AFTER THE HEAD SCAN, WITHOUT THE KNOWLEDGE OF THE OPERATOR, THE PATIENT LOWERED HER ARMS TO THE SIDES OF THE BODY. DURING POSITIONING OF THE SECOND SCAN, THE PATIENT¿S FINGER WAS PINCHED BETWEEN THE TABLETOP AND ITS COVER. AS A RESULT, THE PATIENT SUFFERED AN ABRASION TO THE FINGER. THE PATIENT WAS TREATED WITH MINOR FIRST AID AND NO FURTHER MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: Abrasion

  MAUDE report 17497614 ↗
• MalfunctionJun 5, 2023Delayed Program or Algorithm Execution; Delayed Program or Algorithm Execution

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE NAEOTOM ALPHA CT SYSTEM. ON (B)(6) 2023, A 12-YEAR-OLD FEMALE PATIENT WAS UNDERGOING A CT EXAMINATION. FOLLOWING THE TOPOGRAM, THE SPIRAL SCAN WAS STARTED AND THEN ABORTED. REMOTE TROUBLESHOOTING WITH SIEMENS CUSTOMER SERVICE CORRECTED THE ISSUE TEMPORARILY AND THE SCAN WAS REPEATED SUCCESSFULLY. NO FURTHER NEGATIVE HEALTH CONSEQUENCES WERE REPORTED. SIEMENS HEALTHINEERS CONSIDERS CHILDREN A VULNERABLE PATIENT GROUP, THEREFORE, THIS REPORT IS FILED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060173 ↗
• MalfunctionMay 17, 2023Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE NAEOTOM ALPHA CT SYSTEM. ON (B)(6) 2023, A 6-YEAR-OLD MALE PATIENT UNDERWENT AN INNER EAR EXAMINATION IN WHICH THE SYSTEM HUNG UP DURING THE SCAN. AS A RESULT, A RESCAN OF THE PATIENT WAS NECESSARY. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE PATIENT 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 16950153 ↗
• 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 NEOTOMA ALPHA CT SYSTEM. AFTER A TOPO SCAN OF A 3 YEAR OLD MALE PATIENT, WHEN LOADING THE NEXT SCAN, THE LOADING PROCESS WAS ABORTED WITH AN ERROR. THE USER RESTARTED THE CT SYSTEM AND REPEATED THE TOPOGRAM SCAN WITHOUT SUCCESS. THE PATIENT WAS THEN EXAMINED ON ANOTHER CT SYSTEM. THE PATIENT WAS SEDATED DURING THIS PROCEDURE TO PERFORM THE EXAMINATION. NO NEGATIVE HEALTH CONSEQUENCES WERE REPORTED FOR THE CHILD ASSOCIATED WITH THE REPORTED EVENT. THEREFORE, THIS REPORT HAS BEEN 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 16573768 ↗
• DeathAug 29, 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 NAETOM ALPHA CT SYSTEM. SIEMENS WAS NOTIFIED THAT A PATIENT WITH A SUSPECTED PULMONARY EMBOLISM COULD NOT BE SCANNED ON (B)(6) 2022. THE PATIENT PASSED AWAY, ALTHOUGH, THE EXACT TIME OF DEATH IS UNKNOWN AT THE TIME. DURING INITIAL ANALYSIS, THE SIEMENS SERVICE SPECIALIST FOUND THAT NO VALID CUSTOMER SCAN PROTOCOL FOR PULMONARY EMBOLISM WITH CONTRAST AGENT WAS AVAILABLE. A TECHNICAL INVESTIGATION HAS BEEN STARTED TO DETERMINE WHETHER THE CT SCANNER OR THE CONTRAST AGENT INJECTOR (3RD PARTY DEVICE) MAY HAVE CONTRIBUTED TO THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

  Patient problems: Cardiac Arrest

  MAUDE report 15309899 ↗
• InjuryJul 28, 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 NAEOTOM ALPHA CT SYSTEM. AT THE END OF AN EXAMINATION, DURING HORIZONTAL MOVEMENT OF THE PATIENT TABLE, THE PATIENT´S (90 YEARS, FEMALE) LEFT INDEX FINGER WAS TRAPPED IN THE GAP BETWEEN THE TABLETOP AND TABLE SUPPORT. THE PATIENT WAS SENT TO THE EMERGENCY ROOM OF A HOSPITAL THAT SPECIALIZES IN HAND TREATMENT. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE EXTENT OF THE INJURY NOR HOW HER FINGER WAS MEDICALLY TREATED. ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT RETURNED HOME THE SAME DAY. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Crushing Injury

  MAUDE report 15120744 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211591, K220814, K233657, K243523, K251061. One submission often covers many models, so check the product and lot details in each record.

• Z-1242-2026 · Dec 19, 2025 · Open, Classified
  NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
• Z-1241-2026 · Dec 19, 2025 · Open, Classified
  NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS