OmniTom Elite 0-NL5000-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10815411020663), received between Feb 11, 2025 and Aug 31, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

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

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. Jun 6, 2023Open, Classified

   1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment

   Z-2068-2023 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Communication or Transmission Problem

  The tablet has lost connection to the scanner, resulting in a communication error that potentially delays the treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525506 ↗
• MalfunctionJun 23, 2026Communication or Transmission Problem

  A CRITICAL ERROR FOR THE CONTROL DISCONNECT CAUSED A DELAY IN THE PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596624 ↗
• MalfunctionJun 10, 2026Component or Accessory Incompatibility

  THE TABLET WAS NOT CONNECTING, WHICH DELAYED THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455109 ↗
• MalfunctionMay 19, 2026Appropriate Device Problem Term/Code Not Available

  THE TABLET FROZE TRANSITIONING FROM SCOUT TO SCAN CAUSING THE DELAY IN THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222031 ↗
• MalfunctionMay 13, 2026Appropriate Device Problem Term/Code Not Available

  THE SCANNER DISPLAYED A POWER LOSS DURING SCANNER SETUP FOR THE PATIENT. THE PATIENT WAS NOT SCANNED AND WAS TRANSPORTED TO THE HOSPITAL CAUSING DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165478 ↗
• MalfunctionApr 9, 2026Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS ON THE TABLE, AND THE TABLET WAS NOT CONNECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828921 ↗
• MalfunctionMar 30, 2026Computer Software Problem

  A HELICAL SCAN FAILED IMMEDIATELY FOLLOWING THE COMPLETION OF A DYNAMIC SCAN DURING A BOLUS TRACKING PROTOCOL CAUSING A RE-EXPOSURE AND A DELAY IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737208 ↗
• MalfunctionJan 28, 2026Computer Software Problem

  THE CT SYSTEM TABLET DISCONNECTED WHILE THE PATIENT WAS ON THE TABLE LEADING TO A FAILURE AND LOCK OUT FROM THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200913 ↗
• MalfunctionJan 13, 2026Appropriate Device Problem Term/Code Not Available

  THE BROKEN TRANSLATE BELT WAS CAUSING DELAY IN PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064142 ↗
• MalfunctionDec 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SYTEM STOPPED MIDWAY CAUSING RESCAN AND POTENTIAL DELAY IN THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903983 ↗
• MalfunctionDec 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE TECHNICIAN COULD NOT LOG INTO TABLET CAUSING DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722417 ↗
• MalfunctionNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE TABLET DISCONNECTED FROM THE SCANNER CAUSING A DELAY IN THE PATIENT'S PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659534 ↗
• MalfunctionJul 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE TABLET DISCONNECTED, WHICH CAUSED A DELAY IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22431445 ↗
• MalfunctionJun 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE SYSTEM STOPPED DURING A PATIENT SCAN WITH NO ERROR OR FAULT MESSAGES. TECHNICIAN RESCANNED THE PATIENT, AND THE IMAGES HAD SIGNIFICANT ARTIFACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130459 ↗
• MalfunctionMar 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A MALFUNCTION WITH THE SCANNER CAUSING THE RE-SCAN AND DELAY IN THE PATIENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607429 ↗
• MalfunctionFeb 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE SCANNER STOPPED SCANNING AND DELAYED THE PATIENT'S PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442435 ↗
• MalfunctionFeb 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT PROCEDURE WAS DELAYED BECAUSE THE TUBE WAS HEATING AND PREVENTING THE SCAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360256 ↗