NA GZ-140PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04931921128244), received between Aug 14, 2019 and Aug 8, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2023No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THIS GZ TRANSMITTER IS NOT OUTPUTTING ANY SOUND. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484748 ↗
• MalfunctionMay 11, 2023Data Problem; Data Problem

  THE CUSTOMER REPORTED THAT THE SPO2 WAS SET ON THE SIMULATOR TO 80%, BUT THE READINGS ON THE GZ TRANSMITTER WERE NEAR 85% WHICH IS OUT OF RANGE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916735 ↗
• MalfunctionMay 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WOULD NOT SHOW THE ECG WAVES OR NUMERICS ON THE WIRELESS SURGE SOLUTION (WSS) OR ON THE TRANSMITTER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907554 ↗
• MalfunctionSep 6, 2020No Display/Image; Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WAS NOT DISPLAYING WAVEFORMS, BUT ALL OTHER PARAMETERS AVAILABLE. ISSUE WAS RESOLVED BY REBOOTING THE UNIFIED GATEWAY. NO ERROR MESSAGES DISPLAYED ON THE CENTRAL NURSE'S STATIONS (CNS) WHEN THIS WAS HAPPENING. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10498423 ↗
• MalfunctionAug 4, 2020Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER WAS NOT DISPLAYING WAVEFORMS AND ONLY DISPLAYING NUMERICS. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10360506 ↗
• MalfunctionAug 14, 2019Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THEY ARE HAVING COMMUNICATION ISSUES WITH THE TELEMETRY TRANSMITTERS, AND IT IS VERY INTERMITTENT ACROSS THE 5TH AND 6TH FLOOR. THE ISSUE HAS BEEN GOING ON SINCE THE INSTALL IN FEBRUARY. THIS WAS IN PATIENT USE. WE INQUIRED IF THERE WAS ANY PATIENT HARM REPORTED, AND A RESPONSE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8895588 ↗