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X SERIES 610-2421511-01Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W/PACING,VOICE,12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST · Class 3

All models of X SERIES (163)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946006372), received between Mar 4, 2019 and Nov 18, 2021 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (4 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

Device problems

  • Unable to Obtain Readings4
  • Defibrillation/Stimulation Problem1
  • Failure to Power Up1
  • Pacing Problem1

Patient problems

  • No Patient Involvement2
  • Death1
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 18, 2021Pacing Problem; Unable to Obtain Readings; Defibrillation/Stimulation Problem; Pacing Problem; Unable to Obtain Readings; Defibrillation/Stimulation Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND DISPLAYED A "PACE DEFIB DEVICE FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12837213 ↗
  • MalfunctionAug 9, 2019Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8880699 ↗
  • DeathAug 2, 2019Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT IN CARDIAC ARREST (AGE & GENDER UNKNOWN),THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Patient problems: Death

    MAUDE report 8855818 ↗
  • MalfunctionMar 25, 2019Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8449401 ↗
  • MalfunctionMar 4, 2019Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8387773 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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