NA ZM-530PARecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 04931921115091), received between Feb 9, 2017 and Sep 2, 2026 — classified as 2 deaths, 91 malfunctions.

The most frequently reported specific device problem is “Output Problem” (33 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Unable to Obtain Readings; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570039 ↗
• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE ZM TRANSMITTER WAS PRODUCING INCORRECT ECG HEART RATE (HR) READINGS. IT DISPLAYED TACHYCARDIA WHEN THE PATIENT HAD A NORMAL HR., HE TESTED THE DEVICE ON A SIMULATOR AND GOT THE SAME RESULTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247441 ↗
• MalfunctionMay 4, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GP3 DEPARTMENT HAD A MISMATCH BETWEEN THE TELEMETRY TRANSMITTER AND CENTRAL NURSE'S STATION (CNS). ECG READING WAS GOING UP AND DOWN A LOT WHEN THE PATIENT WAS NORMAL WHEN THEY RAN AN ECG USING A DIFFERENT DEVICE. THIS APPEARS TO HAVE CAUSED SOME INCORRECT ALARMING. THERE WAS ALSO AN EVENT OF SIGNAL LOSS ON THIS BED AROUND THE TIME THAT THIS OCCURRED. WE NEED TO DO AN INVESTIGATION INTO THE INCORRECT ALARMS AND MISMATCHED WAVEFORMS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074391 ↗
• MalfunctionFeb 6, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE MANAGER REPORTED THAT THE ZM TRANSMITTER WAS NOT DISPLAYING THE HEART RATE (HR) AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280430 ↗
• MalfunctionFeb 6, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE MANAGER REPORTED THAT THE ZM TRANSMITTER WAS NOT DISPLAYING THE HEART RATE (HR) AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280290 ↗
• MalfunctionFeb 6, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE MANAGER REPORTED THAT THE ZM TRANSMITTER WAS NOT DISPLAYING THE HEART RATE (HR) AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280117 ↗
• MalfunctionFeb 6, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE MANAGER REPORTED THAT THE ZM TRANSMITTER WAS NOT DISPLAYING THE HEART RATE (HR) AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279348 ↗
• MalfunctionJan 26, 2026Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WAS NOT DISPLAYING VITALS AT THE CENTRAL NURSE STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184943 ↗
• MalfunctionJan 14, 2026No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THIS ZM TRANSMITTER DOES NOT SHOW THE HEART SIGN WHILE SPO2 CONNECTED. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073710 ↗
• MalfunctionDec 17, 2025Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM-530PA TELEMETRY TRANSMITTER IS SHOWING EXCESSIVE NOISE ON THE CENTRAL NURSE'S STATION (CNS). THEY STATED THAT SWAPPING THE TELEMETRY WITH A SPARE UNIT RESOLVED THE ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834860 ↗
• MalfunctionNov 13, 2025Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE ARTIFACT IN THE WAVEFORMS. NEW LEAD SETS TRIED, BUT THE ISSUE PERSISTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550218 ↗
• MalfunctionNov 13, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER (TELE) WAS DROPPING COMMUNICATION. SECTIONS DROP OUT AND COME BACK BEFORE GOING INTO COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23549431 ↗
• MalfunctionNov 13, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER (TELE) WAS DROPPING COMMUNICATION. SECTIONS DROP OUT AND COME BACK BEFORE GOING INTO COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548602 ↗
• MalfunctionNov 6, 2025Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE EXCESSIVE ARTIFACT/NOISE COMING FROM THEIR ZM-530PA. THEY REPORTED THAT EXCESSIVE ARTIFACT/NOISE WAS DETECTED ON THE ZM-530P DURING SETUP BY A NURSE. THERE WAS NO PATIENT HARM, AND THE PATIENT WAS TRANSFERRED TO ANOTHER ZM-530PA. THEY TESTED THE ZM-530PA USING DIFFERENT LEADS, AND THE ISSUE PERSISTED. WHEN USING A REPLACEMENT UNIT WITH THE SAME LEADS, THE ISSUE DID NOT OCCUR, CONFIRMING THAT THE PROBLEM FOLLOWS THE ZM-530PA. HE IS REQUESTING TO EXCHANGE THE UNIT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486577 ↗
• MalfunctionOct 29, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  THE CUSTOMER REPORTED THAT THIS ZM TRANSMITTER IS DRAINING THE BATTERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412969 ↗
• MalfunctionOct 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THE ZM TRANSMITTER GAVE INTERMITTENT SPO2 READINGS. THEY WERE DROPPING FROM THE CENTRAL NURSE'S STATION (CNS). IT WAS CONFIRMED THERE WERE NO ERROR MESSAGES GIVEN WHEN THE READINGS DROPPED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381124 ↗
• MalfunctionOct 15, 2025Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SPO2 CONNECTION CONTINUES TO DROP. HE NOTED NO ERRORS OR MESSAGES APPEARED WHEN THE CONNECTION WOULD DROP. HE CONFIRMED HE SWAPPED THE CABLES WITH KNOWN WORKING SPO2 CABLES, AND THE ISSUE PERSISTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302478 ↗
• MalfunctionAug 26, 2025Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER'S WAVEFORM / SPO2 READINGS WERE DROPPING FROM THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898570 ↗
• MalfunctionNov 6, 2024Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THIS ZM TRANSMITTER WOULD NOT STAY POWERED ON. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622750 ↗
• MalfunctionOct 22, 2024No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THIS UNIT IS NOT READING THE ECG. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506138 ↗
• MalfunctionSep 3, 2024Incorrect, 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 WAS SHOWING AN INCORRECT HEART RATE AT THE CENTRAL NURSES STATION (CNS) WHEN IN PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125746 ↗
• MalfunctionJul 26, 2024Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER FREQUENTLY LOST ECG WAVEFORMS. IT WOULD FLATLINE AND NOT GIVE ANY READINGS OR ERROR MESSAGES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19845324 ↗
• MalfunctionMar 13, 2024Display or Visual Feedback Problem; Image Display Error/Artifact; Output Problem; Display or Visual Feedback Problem; Image Display Error/Artifact; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE HEART RHYTHMS FROM THIS TELEMETRY TRANSMITTER (TELE) ARE SHOWING ARTIFACTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899291 ↗
• MalfunctionJan 17, 2024Data Problem; Data Problem

  THE CUSTOMER REPORTED BEING UNABLE TO REVIEW DATA ON THIS CENTRAL NURSE'S STATION (CNS) FOR THEIR TELE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527782 ↗
• MalfunctionMar 30, 2023Patient Data Problem; Patient Data Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER WAS READING OUT OF CALIBRATION ON A FEW PATIENTS AND WAS SHOWING INACCURATE READINGS. THE BME REPORTED THERE WAS NO ERROR MESSAGES WHEN THIS OCCURRED. UNIT WAS TAKEN OUT OF USE SO NO HARM OCCURRED, STAFF JUST CHECKED SPO2 WITH ANOTHER DEVICE. BME DID SOME TROUBLESHOOTING AND DURING TESTING FOUND: SIMULATED 85% READS 80%, SIMULATED 95% READS 100%, SIMULATED 85% AGAIN, THIS TIME READS 98%. THE BME TRIED DIFFERENT CABLE/PROBES, VERY ERRATIC. NIHON KOHDEN TECHNICAL SUPPORT SENT THE BME A WARRANTY REPLACEMENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16651229 ↗