cap-ONE TG-970PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04931921885635), received between Jul 28, 2021 and Jul 28, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Output 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionJul 28, 2021Output Problem; Output Problem

  THE SLEEP, EEG, EVS MANAGER REPORTED THAT THEY NOTICED THE HIGH VALUES AND WENT TO CHECK ON THE PATIENT. THEY THEN DECIDED TO CHECK OTHER CABLES AND FOUND THAT THIS TG-970P, CO2 SENSOR KIT, WAS GIVING INACCURATE READING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243016 ↗
• MalfunctionJul 28, 2021Output Problem; Output Problem

  THE SLEEP, EEG, EVS MANAGER REPORTED THAT THEY NOTICED HIGH VALUES AND WENT TO CHECK ON THE PATIENT. THEY THEN DECIDED TO CHECK OTHER CABLES AND FOUND THAT THIS TG-970P, CO2 SENSOR KIT, WAS GIVING INACCURATE READINGS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242980 ↗