BodyTom 64 0-NL4100-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10815411020533), received between Jan 11, 2025 and Jun 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

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.

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.

• MalfunctionJun 23, 2026Image Display Error/Artifact

  THE SCANNER MOVED OVER THE PATIENT AS EXPECTED, THE X-RAY LIGHT DID NOT ACTIVATE. IN ESSENCE, THE SCANNER FAILED TO EMIT X-RAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596622 ↗
• MalfunctionMay 19, 2026Human-Device Interface Problem

  THE SYSTEM EXPERIENCED TWO LOCKUPS, REQUIRING A REBOOT EACH TIME. ADDITIONALLY, THE SCANNER IS DISPLAYING A MESSAGE INDICATING THAT THE X-RAY TUBE NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225284 ↗
• MalfunctionMar 20, 2026Computer Software Problem

  THE PATIENT WAS ON THE TABLE WHEN AN ERROR (CODE 54) OCCURRED, RESULTING IN A DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654466 ↗
• MalfunctionFeb 5, 2026Data Back-Up Problem

  THE MACHINE DISPLAYS A GRAY SCREEN AND DOES NOT ALLOW PROGRESSION CAUSING THE DELAY IN THE PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273792 ↗
• MalfunctionFeb 4, 2026Contamination /Decontamination Problem

  THE RECONSTRUCTION OFFSET PROTOCOL (ERROR 54) STATED THAT THE PHANTOM WAS NOT PRESENT AND THE PATIENT SCAN NEEDED TO BE COMPLETED WITH A DIFFERENT MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263841 ↗
• MalfunctionDec 14, 2025Use of Device Problem; Use of Device Problem

  AN ISSUE DURING SCANNING WAS CAUSING THE DEVICE TO RESET TO THE HOME SCREEN, RESULTING IN POTENTIAL DELAY IN PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799906 ↗
• MalfunctionNov 26, 2025No Display/Image; No Display/Image

  WHILE OPERATING THE SYSTEM, THE USER OBSERVED THAT THE SCANNER'S STATUS INDICATOR WAS NOT DISPLAYING THE EXPECTED BLUE LIGHT. SHORTLY AFTERWARD, THE SCANNER SCREENS WENT BLANK AND THE SYSTEM LOST CONNECTION TO THE WORKSTATION CAUSING DELAY IN THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659521 ↗
• MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THERE WAS AN ISSUE WITH A FAULTY COMPONENT DUE TO THAT THE PATIENT WAS TRANSFERRED TO AN ALTERNATE SYSTEM FOR RESCANNING, WHICH RESULTED IN A TREATMENT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931149 ↗
• MalfunctionJul 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD TO BE RESCANNED DUE TO ARTIFACT IN THE IMAGES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22416632 ↗
• MalfunctionApr 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE CT SOFTWARE APPLICATION FROZE, WHICH RESULTED A RE-SCAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777662 ↗
• MalfunctionJan 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE TECHNICIAN ACCIDENTALLY DELETED A PATIENT FROM THE BROWSER, WHICH REQUIRES A RE-SCAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132882 ↗