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X SERIES 610-2231511-01-66Recalls & reported problems

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

All models of X SERIES (163)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847946018207), received between Jul 18, 2019 and May 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (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

Device problems

  • Reset Problem2
  • Failure to Power Up1
  • Unable to Obtain Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 25, 2022Failure to Power Up; Failure to Power Up

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14498420 ↗
  • MalfunctionMay 20, 2022Unable to Obtain Readings; Unable to Obtain Readings

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A 62-YEAR-OLD MALE PATIENT, 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 THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14458301 ↗
  • MalfunctionAug 4, 2020Reset Problem; Reset Problem

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE RESTARTED/REBOOTED ITSELF MULTIPLE TIMES. 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 10364426 ↗
  • MalfunctionJul 18, 2019Reset Problem; Reset Problem

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE RESET/REBOOT ITSELF. 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 8803712 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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