NA ZM-540PARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04931921106600), received between Feb 21, 2017 and Jun 30, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Power Problem; Complete Loss of Power

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WOULD NOT STAY POWERED ON. HE STATED THAT WITH NEW BATTERIES, IT WOULD SOMETIMES POWER OFF ON ITS OWN AS IF THERE WAS A BATTERY TERMINAL OR CONNECTION ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668723 ↗
• MalfunctionJun 15, 2026Power Problem; Complete Loss of Power

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS TRANSMITTER FAILED THE AIR LEAK TEST AND SHUTS DOWN. DISCOVERED DURING TESTING AND NOT IN PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505346 ↗
• MalfunctionSep 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE NURSE REPORTED THAT THEY COULD ONLY SEE ONE LEAD UNDER THE 12-LEAD DATA PAGE ON THE CENTRAL NURSE STATION (CNS) FOR THIS ZM TRANSMITTER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133264 ↗
• MalfunctionSep 10, 2020Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER WAS NOT READING ECG LEADS AND THERE WAS NO ERROR MESSAGE. THE MONITORING TECH NOTICED IT WHEN THEY WENT INTO FULL DISCLOSURE AND ONLY SAW A QRS WAVE ON LEAD 2. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10519156 ↗
• MalfunctionFeb 28, 2019Overheating of Device; Overheating of Device

  THE BIOMED REPORTED THAT THE MIDDLE BATTERY IS SHORTING OUT AND BELIEVES IT IS THAT TERMINAL THAT IS GETTING HOT AND CAUSING THE DEVICE TO SHUT DOWN. CUSTOMER WAS PROVIDED AN EXCHANGE TRANSMITTER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380439 ↗
• MalfunctionAug 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THE TRANSMITTER HAS AN SPO2 FAILURE. NO ADDITIONAL INFORMATION REGARDING THE EVENT IS AVAILABLE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839601 ↗
• MalfunctionAug 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER GAVE INCORRECT ECG READINGS. THE HEART RATE WAS RANDOMLY GOING TO HIGH NUMBERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772666 ↗
• MalfunctionAug 17, 2017Electrostatic Discharge; Temperature Problem; Electrostatic Discharge; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE NURSE WAS SHOCKED WHEN TRYING TO PLACE BATTERIES INTO THE TRANSMITTER. THE BIOMEDICAL ENGINEER THEN TESTED THE DEVICE AND THE BATTERIES OVERHEATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802653 ↗
• MalfunctionFeb 21, 2017Device Alarm System; No Audible Alarm; Alarm Not Visible; Device Alarm System; No Audible Alarm; Alarm Not Visible

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER DID NOT V-FIB ALARM WHILE THE PATIENT WAS BEING MONITORED ON THE CNS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348143 ↗
• MalfunctionFeb 21, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER'S BATTERY OVERHEATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348134 ↗