X SERIES 610-2221410-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847946005986), received between Jul 17, 2017 and May 20, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "ECG DISABLED" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 25234412 ↗
• MalfunctionApr 24, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981820 ↗
• MalfunctionApr 16, 2026Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE EXPERIENCED ECG MONITORING FAILURE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24899109 ↗
• MalfunctionDec 19, 2025Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITORA PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849916 ↗
• MalfunctionJun 26, 2024Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613109 ↗
• MalfunctionMar 27, 2024Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985965 ↗
• MalfunctionJun 14, 2023Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" ERROR MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATE THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17128959 ↗
• MalfunctionFeb 21, 2023Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408538 ↗
• MalfunctionOct 28, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693436 ↗
• MalfunctionAug 19, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" ERROR MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260812 ↗
• MalfunctionAug 15, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" ERROR MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224296 ↗
• MalfunctionJan 26, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST FOR ECG FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359433 ↗
• MalfunctionJul 12, 2021Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12152924 ↗
• MalfunctionMay 13, 2020Unable to Obtain Readings; Unexpected Shutdown; Unable to Obtain Readings; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN AND WHEN THE DEVICE WAS POWERED ON THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 10052484 ↗
• MalfunctionJan 6, 2020Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 9554964 ↗
• MalfunctionMay 16, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE MONITORING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7518907 ↗
• MalfunctionJul 17, 2017Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6716882 ↗