NA GZ-120PRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04931921117392), received between Apr 17, 2018 and Mar 3, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Output Problem” (5 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Device Alarm System; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT 80% OF THEIR GZ TRANSMITTERS WERE NOT ALARMING WHEN THE BATTERIES WERE WEAK WHEN ON STANDBY WAITING TO BE USED. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494990 ↗
• MalfunctionSep 15, 2025No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS, SN: (B)(6) WAS NOT ALARMING AUDIBLY WHEN THE GZ TRANSMITTER (SN: (B)(6) HAD A LOW BATTERY. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051588 ↗
• MalfunctionSep 11, 2025Electrical /Electronic Property Problem; Communication or Transmission Problem; Electrical /Electronic Property Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WAS EXPERIENCING INTERMITTENT SIGNAL LOSS AND IT WOULD RANDOMLY TURN OFF. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025231 ↗
• MalfunctionMay 7, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WOULD NOT PICK UP ALL SIX ECG LEADS DESPITE TRYING DIFFERENT LEADS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259306 ↗
• MalfunctionApr 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE GZ TRANSMITTER HAD INTERMITTENT WAVEFORM DROPOUT AND FLATLINING. NO PHYSICAL DAMAGE OR FLUID INTRUSION WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203426 ↗
• MalfunctionDec 27, 2023Erratic or Intermittent Display; Protective Measures Problem; Intermittent Communication Failure; Erratic or Intermittent Display; Protective Measures Problem; Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER EXPERIENCED INTERMITTENT ECG WAVEFORMS AND DID NOT DISPLAY AN ERROR MESSAGE. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397917 ↗
• MalfunctionNov 2, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  THE BIOMEDICAL ENGINEER REPORTED THAT THE GZ TRANSMITTER WAS PRODUCING A LARGE AMOUNT OF ARTIFACT FOR THE ECG INTERMITTENTLY AND HAS HAPPENED MULTIPLE TIMES ON MULTIPLE PATIENTS AND MULTIPLE LEAD SETS HAVE BEEN TRIED. NO PATIENT HARM OCCURRED. THE BIOMEDICAL ENGINEER REQUESTED A WARRANTY EXCHANGE AND RETURNED THIS UNIT TO NIHON KOHDEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062471 ↗
• MalfunctionAug 2, 2023Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER HAD SHUT DOWN DUE TO OVERHEATING AND COULD NOT BE TURNED BACK ON UNTIL IT HAD COOLED DOWN. NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443189 ↗
• MalfunctionMar 9, 2023Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THIS UNIT WILL POWER OFF ON ITS OWN. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16517763 ↗
• MalfunctionDec 16, 2022Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT AFTER IT WAS REMOVED FROM THE PATIENT AND WHEN GOING TO TURN IT OFF, THE NURSES NOTICED THAT THE DEVICE WAS VERY HOT. THEREFORE, THEY LEFT IT ON THE COUNTER TO COOL DOWN. THE NURSES REPORTED THAT THE BATTERY WAS VERY SWOLLEN AND THAT THE BATTERY ACID EVENTUALLY BEGAN LEAKING OUT ONTO THE GZ TELEMETRY TRANSMITTER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000834 ↗
• MalfunctionMar 18, 2021Power Problem; Intermittent Loss of Power; Power Problem; Intermittent Loss of Power

  THE BIOMEDICAL ENGINEER REPORTED THAT THE GZ TELEMETER'S BATTERY CONTACT WAS BROKEN, CAUSING THE TELEMETER TO LOSE POWER INTERMITTENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516611 ↗
• MalfunctionMar 18, 2021Power Problem; Intermittent Loss of Power; Power Problem; Intermittent Loss of Power

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TELEMETER'S BATTERY CONTACT WAS BROKEN, CAUSING IT TO INTERMITTENTLY LOSE POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516404 ↗
• MalfunctionMar 11, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG WAVEFORMS SENT TO THE CENTRAL NURSE'S STATION (CNS) FROM THE GZ TRANSMITTER WERE INTERMITTENTLY DROPPING OFF THE CNS. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464672 ↗
• MalfunctionMar 7, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT WAVEFORM DISPLAYS ON THE GZ TRANSMITTER BUT DOES NOT DISPLAY ON THE CENTRAL NURSE'S STATION (CNS). THEY STATED THAT THIS EXCHANGE UNIT HAD NO ISSUES PRIOR TO (B)(6) 2021. THE ECG WAVEFORM WERE GOOD, AND THE CNS SHOWED A GOOD ECG WAVEFORM FOR A FEW SECONDS AND BLANKED OUT WITH NO LINES OR ANYTHING. THIS PROCESS WOULD REPEAT. THEY HAD TRIED STOPPING MONITORING AND THEN STARTING MONITORING AND NEW BATTERIES. NO LEADS ATTACHED (WILL FOLLOW UP WITH CUSTOMER ON THIS ONE). NO PHYSICAL DAMAGE / FLUID INTRUSION. AUTO IP. AUTO ON WIRELESS BAND, BUT IT SHOULD BE 5GHZ BAND. STOPPED COMMUNICATING WITH SERVER ON (B)(6) 2021. THEN THE CUSTOMER PUT A TELEMETRY TRANSMITTER ON PATIENT AND WAS UNABLE TO TRANSFER PATIENT DATA TO ANOTHER GZ. THEY WERE UNABLE TO DISCHARGE PATIENT FOR A WHILE BUT EVENTUALLY GOT IT TO DISCHARGE FROM THE BOX ITSELF. THEY READMITED THE DEVICE TO MOVE PATIENT DATA TO DIFFERENT GZ. THEY COMPARED SETTINGS BETWEEN THIS TRANSMITTER WITH A KNOWN WORKING TRANSMITTER AND EVERYTHING WAS EXACTLY THE SAME. THE FAILED GZ SHOWED CHANGES ONCE HE GOT IT TO DISCHARGE, BUT THE CNS DOES NOT. THERE ARE COMMUNICATION ISSUES BETWEEN THIS GZ AND THE CNS. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429568 ↗
• MalfunctionNov 4, 2020Application Program Problem; Output Problem; Application Program Problem; Output Problem

  THE NURSE REPORTED THAT THEY HAD LOST DATA FOR 2 PATIENTS, THEY DISAPPEARED FROM THE PATIENT TILE ON THE CENTRAL NURSE'S STATION (CNS), AND THEY WERE NO LONGER GETTING WAVEFORMS AND THE PATIENT NAME AND ID DISAPPEARED. PATIENT WAS ADMITTED TO THE CNS. THEN THEY SAW THAT THE PATIENT DISAPPEARED OFF THE PATIENT TILE. IT SEEMED AS IF THEY WERE NOT ADMITTED TO THE CNS. THE FIRST INSTANCE HAPPENED YESTERDAY ON (B)(6) 2020 AT AROUND 7:30 AM TO 8:00 AM WHEN THEY NOTICED THAT THE PATIENT DISAPPEARED. THEY RE-ENTERED THE PATIENT ID, AND THEY WERE ABLE TO PUT THEM BACK ON THE CNS. THE SECOND INSTANCE HAPPENED ON (B)(6) 2020 AT 9:20 AM, THE PATIENT WAS ADMITTED AT 7:30 AM AND THEY NOTICED THE PATIENT DISAPPEARED AT 9:20AM. ALL THE DATA FROM 7:30 AM TO 9:20 AM WAS LOST DUE TO THIS. THIS PATIENT WAS ON A GZ-120PA SN: (B)(4). SOFTWARE VERSION (B)(4). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10789040 ↗
• MalfunctionAug 27, 2020Computer Software Problem; Application Program Problem; Output Problem; Computer Software Problem; Application Program Problem; Output Problem

  THE CLINICAL INFORMATICS NURSE REPORTED THAT THE PATIENT NAME AND PATIENT ID DISAPPEARED FROM THE CENTRAL NURSE'S STATION (CNS) PATIENT TILE BUT THE VITALS REMAINED. THE PATIENT WAS BEING MONITORED ON A TELEMETRY TRANSMITTER. THIS ONLY HAPPENED WITH THIS TRANSMITTER ONCE. THEN THE NURSE RE-ENTERED THE PATIENT ID AND THE PATIENT NAME CAME BACK ON THE TILE. AT THIS POINT, THEY ARE NOT HAVING THE ISSUE, AND THIS SEEMS TO BE ISOLATED INCIDENT AT THIS TIME. NO PATIENT HARM REPORTED.

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

  MAUDE report 10463383 ↗
• MalfunctionAug 21, 2020Application Program Problem; Application Program Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE GZ TRANSMITTER DISCHARGED THE PATIENT, POSSIBLY WITHOUT USER INTERVENTION.

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

  MAUDE report 10440388 ↗
• MalfunctionAug 20, 2020Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE NURSE REPORTED THAT THE TELEMETRY TRANSMITTER IS GETTING HOT AND DEPLETING BATTERIES QUICKLY COMPARED TO OTHER TRANSMITTERS AND FEELS "HOT" TO THE TOUCH. THEY FOUND IT TO BE HOT WHEN THEY WENT TO CHANGE THE BATTERIES. ALSO, SIGNAL LOSS WOULD SHOW ON THE CENTRAL NURSE'S STATION (CNS) WHEN THE IT BECAME HOT. NO PATIENT HARM REPORTED.

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

  MAUDE report 10434661 ↗
• MalfunctionJun 4, 2020Computer Software Problem; Loss of Data; Data Problem; Patient Data Problem; Patient Device Interaction Problem; Computer Software Problem; Loss of Data; Data Problem; Patient Data Problem; Patient Device Interaction Problem

  THE CLINICAL INFORMATICS NURSE REPORTED THAT THE PATIENTS ARE GETTING DISCHARGED FROM THE TELEMETRY TRANSMITTER AND ALL THE DATA IS GETTING DELETED FROM IT. WE ARE NOT SURE IF THE TRANSMITTERS ARE DISCHARGING THEMSELVES, OR IF THIS IS AN USER ERROR WHERE THE CONTROL BUTTONS ARE NOT LOCKED AND PREVENTING THE DISCHARGE OF THE UNIT WHEN THE PATIENT ROLLS OR TOUCHES THE UNIT, OR IF THIS IS AN USER ERROR WHERE SOMEONE IS DISCHARGING THE PATIENT BY ACCIDENT. THE LOGS ARE BEING COLLECTED FOR INVESTIGATION. NO PATIENT HARM REPORTED.

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

  MAUDE report 10121470 ↗
• MalfunctionJun 4, 2020Computer Software Problem; Loss of Data; Data Problem; Patient Data Problem; Patient Device Interaction Problem; Computer Software Problem; Loss of Data; Data Problem; Patient Data Problem; Patient Device Interaction Problem

  THE CLINICAL INFORMATICS NURSE REPORTED THAT THE PATIENTS ARE GETTING DISCHARGED FROM THE TELEMETRY TRANSMITTER AND ALL THE DATA IS GETTING DELETED FROM IT. WE ARE NOT SURE IF THE TRANSMITTERS ARE DISCHARGING THEMSELVES, OR IF THIS IS AN USER ERROR WHERE THE CONTROL BUTTONS ARE NOT LOCKED AND PREVENTING THE DISCHARGE OF THE UNIT WHEN THE PATIENT ROLLS OR TOUCHES THE UNIT, OR IF THIS IS AN USER ERROR WHERE SOMEONE IS DISCHARGING THE PATIENT BY ACCIDENT. THE LOGS ARE BEING COLLECTED FOR INVESTIGATION. NO PATIENT HARM REPORTED.

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

  MAUDE report 10121407 ↗
• MalfunctionJun 4, 2020Computer Software Problem; Loss of Data; Data Problem; Computer Software Problem; Loss of Data; Data Problem

  THE CLINICAL INFORMATICS NURSE REPORTED THAT THE PATIENTS ARE GETTING DISCHARGED FROM THE TELEMETRY TRANSMITTER AND ALL THE DATA IS GETTING DELETED FROM IT. WE ARE NOT SURE IF THE TRANSMITTERS ARE DISCHARGING THEMSELVES, OR IF THIS IS AN USER ERROR WHERE THE CONTROL BUTTONS ARE NOT LOCKED AND PREVENTING THE DISCHARGE OF THE UNIT WHEN THE PATIENT ROLLS OR TOUCHES THE UNIT, OR IF THIS IS AN USER ERROR WHERE SOMEONE IS DISCHARGING THE PATIENT BY ACCIDENT. THE LOGS ARE BEING COLLECTED FOR INVESTIGATION. NO PATIENT HARM REPORTED.

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

  MAUDE report 10120385 ↗
• MalfunctionMar 31, 2020Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THEIR GZ TRANSMITTER IS OVERHEATING WHEN IN MONITOR MODE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9903647 ↗
• MalfunctionMar 19, 2020Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE NURSE MANAGER REPORTED THAT THE TRANSMITTER WAS HAVING A HIGHER THAN USUAL TEMPERATURE. THE PATIENT COMPLAINED THAT IT WAS HOT. THEY TOOK IT OUT OF SERVICE AND HAD A CE RUN A SERIES OF TESTS ON IT. NONE OF THE TESTS WERE CONCLUSIVE. NIHON KOHDEN TECHNICAL SUPPORT BELIEVES THAT THE HIGHEST TEMP THEY REACHED WAS AROUND 100 DEGREES F. NO PATIENT HARM REPORTED. THE CUSTOMER LATER COMMUNICATED TO NK THAT THEY BELIEVE THAT THIS WAS AN ISOLATED AND PATIENT SPECIFIC ISSUE. UPON ASSESSING, THE PACK WAS NOT "HOT" ENOUGH TO CAUSE BURNS, NO BURNS WERE NOTED ON PATIENT EXAM AND THE PACK WAS WARM TO THE TOUCH (AS MOST BATTERY OPERATED ITEMS GET WHEN USED FOR A PROLONGED PERIOD OF TIME). NK'S CLINICAL ENGINEERING TEAM WAS NOT ABLE TO RECREATE THIS NOR HAS NK NOTICED THIS IN ANY OTHER PACK. NK DID NOT WANT TO SEND IT TO QUALITY ASSURANCE IT WAS FELT IT WAS A SUBJECTIVE COMPLAINT FROM THE PATIENT THAT WAS NOT NECESSARILY FACTUAL.

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

  MAUDE report 9857818 ↗
• MalfunctionAug 27, 2019Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE ONSITE NIHON KOHDEN CLINCAL APPLICATION SPECIALIST REPORTED THAT THE TRANSMITTER WAS IN PATIENT USE AND STARTED MAKING BUZZING SOUNDS AND GETTING A "ROOM NOT REGISTERED" MESSAGE. THE TRANSMITTER AND THE BATTERIES WERE EXTREMELY HOT. NO PATIENT HARM REPORTED.

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

  MAUDE report 8936278 ↗
• MalfunctionAug 13, 2019Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE ALL OVER THE BOARD, AND WHEN TESTING THE TRANSMITTER ON A SIMULATOR, THE HEART RHYTHM READING JUMPED AROUND FROM 120 TO 150 TO 80. THE SIMULATOR WAS SET AT 80.

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

  MAUDE report 8891036 ↗