NA ZM-520PARecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04931921115077), received between Apr 4, 2017 and Sep 16, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (12 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025No Device Output; Output Problem; No Device Output; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER WILL NO LONGER READ THE VA LEAD. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069132 ↗
• MalfunctionFeb 2, 2024Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WAS SHOWING ARTIFACT/NOISES WITHIN THE WAVEFROMS WHILE IN PATIENT USE. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICAL SUPPORT HAD THE BME UN-MONITOR AND RE- MONITOR THE DEVICE AND THE BME REPORTED THE WAVEFORM BECOMES INTERMITTENT AFTERWARDS, THAT IT WOULD HAVE NO ARTIFACTS AT FIRST THEN WITHIN 1 MINUTE IT STARTS HAVING ARTIFACTS. NK TECHNICAL SUPPORT HAD THE BME TURN ON THE HUM FILTER WITHIN THE CNS BUT WHEN THE BME DID THE PROBLEM STILL PERSISTED. NK TECHNICAL SUPPORT HAD THE BME CHANGE THE ZM WITH NEW CABLES AND CLEAN THE CONNECTOR ON THE ZM ITSELF BUT THE ISSUE IS STILL PERSISTING. NK TECHNICAL SUPPORT HAD THE BME CHANGE THE ZM TRANSMITTER WITH A SPARE UNIT AND THE WAVEFORMS WERE NO LONGER HAVING ARTIFACTS. BME REQUESTED TO SEND THEIR ZM TRANSMITTER INTO NIHON KOHDEN FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636926 ↗
• MalfunctionFeb 16, 2021Computer Software Problem; Data Problem; Patient Data Problem; Computer Software Problem; Data Problem; Patient Data Problem

  THE BIOMED REPORTED THAT THE PREVIOUS DAY A PATIENT HAD CODED AND THEY NOTICED DATA WAS NOT RECORDED. THE DATA HAD ABOUT A 10-11MIN GAP WHERE IT WAS BLANK. WAVEFORMS WERE STILL DISPLAYING ON THE SCREEN BUT NOT RECORDED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335638 ↗
• MalfunctionFeb 16, 2021Patient Data Problem; Patient Data Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT A PATIENT CODED THE PREVIOUS DAY WHILE BEING MONITORED ON A TELEMETRY TRANSMITTER AND FOUND THAT THERE WAS A GAP OF ABOUT 10-11 MINUTES OF RECORDED DATA. WAVEFORMS WERE STILL DISPLAYING ON THE SCREEN BUT NOT RECORDING. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334566 ↗
• MalfunctionSep 16, 2020Overheating of Device; Unable to Obtain Readings; Output Problem; Temperature Problem; Overheating of Device; Unable to Obtain Readings; Output Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER WAS EXPERIENCING ECG DROPOUTS. THEY ALSO BELIEVE THE ECG BOARD MIGHT BE OVERHEATING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10543551 ↗
• MalfunctionJul 7, 2020Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER STARTED TO HEAT UP AND GOT TOO HOT TO TOUCH OR HOLD. NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 10242149 ↗
• MalfunctionJun 18, 2020Device Alarm System; Protective Measures Problem; Device Alarm System; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THEIR TRANSMITTER MISSED AN ARRHYTHMIA ALARM. NO PATIENT HARM OR INJURY WAS REPORTED.

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

  MAUDE report 10171763 ↗
• MalfunctionMay 20, 2020Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE BATTERIES WERE HOT IN THE TELEMETRY TRANSMITTER. THEY REPLACED THE BATTERIES, BUT THE ISSUE PERSISTED. THEY REQUESTED THAT THE UNIT BE REPAIRED. NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 10075969 ↗
• MalfunctionMar 19, 2020Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  THE CUSTOMER REPORTED THAT THEIR TRANSMITTER BATTERY WAS SHORTING IF THEY PLACED THE BATTERY INSIDE OF THE TRANSMITTER WITH THE NEGATIVE END FIRST.

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

  MAUDE report 9857827 ↗
• MalfunctionDec 13, 2019Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER OVERHEATED AND THE TEMPERATURE FEELS HIGHER THAN USUAL, IN THE REAR OF THE TRANSMITTER, PARTICULARLY IN THE BATTERY AREA WHERE THE BATTERIES CONNECT. THE TRANSMITTER STILL WORKS AND TRANSMITS WAVEFORMS AND VITAL SIGNS AS NORMAL. THERE IS NOTHING ELSE WRONG WITH IT OTHER THAN IT BEING SUPER WARM IN THE REAR, BATTERY AREA. NO PATIENT HARM REPORTED.

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

  MAUDE report 9470244 ↗
• MalfunctionNov 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT ONE OF THEIR TRANSMITTER WAS NOT DISPLAYING ANY HEART RATE READINGS. THE CUSTOMER ALSO REPORTED THAT THIS TRANSMITTER WAS NOT SENDING THE HEART RATE READING TO THE CENTRAL NURSE'S STATION (CNS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373390 ↗
• MalfunctionNov 11, 2019Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTS THAT THE TRANSMITTER BATTERIES WILL GET VERY HOT WHEN PUT IN THE DEVICE AND IT WILL NOT TURN ON. NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 9307254 ↗
• MalfunctionAug 29, 2019Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED CAUSING THE BATTERY COMPARTMENT TO MELT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8947890 ↗
• MalfunctionAug 14, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER SENT NO WAVE OR NUMERICS TO THE CENTRAL NURSE'S STATION (CNS) AND DID NOT DISPLAY THEM LOCALLY.

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

  MAUDE report 8895549 ↗
• MalfunctionMar 1, 2019Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER'S BATTERY OVERHEATED AND SPLIT APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8382895 ↗
• MalfunctionDec 26, 2018Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED SIGNAL LOSS ON MULTIPLE CHANNELS. NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8198083 ↗
• MalfunctionAug 21, 2018Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE TRANSMITTER DROPPED TRANSMISSION OF THE PATIENT'S VITAL SIGNS WHILE ATTEMPTING A PATIENT TRANSFER BACK TO THE BEDSIDE. THE TRANSMITTER'S DISPLAY ALSO WENT BLANK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7803709 ↗
• MalfunctionAug 8, 2018Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER OVERHEATED AND MELTED THE BATTERY COMPARTMENT. THEY SENT THE TRANSMITTER IN FOR EVALUATION AND RECEIVED AN EXCHANGE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME. THE BATTERIES REQUIRED FOR THIS INVESTIGATION WERE NOT RETURNED. NEW BATTERIES WERE INSERTED INTO THE UNIT AND HEATING COULD NOT BE DUPLICATED. INSPECTION OF THE NEGATIVE CONTACTS SHOWED THAT THERE WERE RESIN MELT MARKINGS AT THE SPRING, WHICH PER AN NKC INVESTIGATION ON A SIMILAR INCIDENT, IS INDICATIVE OF IMPROPER BATTERY INSERTION. ALSO NOTED WAS CORROSION AT THE POSITIVE CONTACT INDICATING FLUID INTRUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7764782 ↗
• MalfunctionJun 28, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Interpretation of Signal; Invalid Sensing; Device Sensing Problem; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Interpretation of Signal; Invalid Sensing; Device Sensing Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER IS NOT GETTING CORRECT READINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648783 ↗
• MalfunctionApr 20, 2018Overheating of Device; Device Issue; Human Factors Issue; Misassembly by Users; Overheating of Device; Device Issue; Human Factors Issue; Misassembly by Users

  THE CUSTOMER REPORTED THAT THE TRANSMITTER WAS OVERHEATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448219 ↗
• MalfunctionMar 13, 2018Inappropriate/Inadequate Shock/Stimulation; Device Issue; Inappropriate/Inadequate Shock/Stimulation; Device Issue

  THE CUSTOMER REPORTED THAT A PATIENT COMPLAINED OF GETTING SHOCKED BY THE ECG ELECTRODES THAT WERE ATTACHED TO THE TRANSMITTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335978 ↗
• MalfunctionFeb 28, 2018Thermal Decomposition of Device; Overheating of Device; Temperature Problem; Thermal Decomposition of Device; Overheating of Device; Temperature Problem

  THE NURSE REPORTED THAT THE BATTERIES IN THE TRANSMITTER WERE OVERHEATING BUT THE BIOMEDICAL ENGINEER REPORTED THERE WAS NO OVERHEATING AND THAT HE KEPT GETTING SPORADIC READINGS, A "CHECK LEADS" ERROR MESSAGE, AND A FLAT LINE WHILE ON THE SIMULATOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304956 ↗
• MalfunctionSep 11, 2017Overheating of Device; Smoking; Temperature Problem; Overheating of Device; Smoking; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER OVERHEATED AND WAS SMOKING. THE BATTERY CONTACTS WERE BURNED AND MELTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6855773 ↗
• MalfunctionApr 4, 2017Device Emits Odor; Smoking; Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT WHILE PREPARING THE TRANSMITTER FOR PATIENT USE, THE TRANSMITTER HAD A BURNING SMELL AND BEGAN TO SMOKE. THE TRANSMITTER HAD JUST BEEN USED ON ANOTHER PATIENT WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6459175 ↗