TCM 4 series ETX base unit 391-880Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05700693918808), received between Apr 2, 2025 and Dec 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE TCM 4 SERIES ETX BASE UNIT (SERIAL NUMBER (B)(6) COMPLETES CALIBRATION SUCCESSFULLY AND DISPLAYS "READY." ELECTRODES ARE APPLIED TO THE PATIENT'S SKIN FOR MONITORING, AND MEASUREMENTS APPEAR ON THE SCREEN AS EXPECTED. HOWEVER, AFTER CONTINUOUS MONITORING FOR A PERIOD (AS SHORT AS A FEW MINUTES OR AS LONG AS 10-20 MINUTES), THE SCREEN SUDDENLY SHOWS "GENERAL ERROR," AND THE MACHINE STOPS MONITORING. PREVIOUSLY RECORDED DATA IS NOT LOST; IT IS SAVED IN THE PATIENT DATABASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766424 ↗
• MalfunctionDec 10, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, THE TCM 4 SERIES ETX BASE UNIT (SERIAL NUMBER (B)(6)) COMPLETES CALIBRATION SUCCESSFULLY AND DISPLAYS "READY." ELECTRODES ARE APPLIED TO THE PATIENT'S SKIN FOR MONITORING, AND MEASUREMENTS APPEAR ON THE SCREEN AS EXPECTED. HOWEVER, AFTER CONTINUOUS MONITORING FOR A PERIOD (AS SHORT AS A FEW MINUTES OR AS LONG AS 10-20 MINUTES), THE SCREEN SUDDENLY SHOWS "GENERAL ERROR," AND THE MACHINE STOPS MONITORING. PREVIOUSLY RECORDED DATA IS NOT LOST; IT IS SAVED IN THE PATIENT DATABASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766343 ↗
• MalfunctionApr 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 DURING THE MONITORING OF THE PATIENT TCPO2 AND TCPCO2, THE TCM MONITOR (SERIAL NUMBER: (B)(6) DISPLAY PANEL SUDDENLY SHUT DOWN AND COULD NOT BE RESTARTED. THIS RESULTED IN THE INABILITY TO CONTINUE THE MONITORING OF THE PATIENT, LEADING TO AN ARTERIAL BLOOD SAMPLE DRAWN INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750030 ↗