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X SERIES 610-2231001-01Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NO NIBP, SPO2, SPCO, CPR EXPANSION PACK AND ETCO2, W/CP2, DMST · 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
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847946018177), received between Dec 9, 2021 and May 11, 2022 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Delayed Charge Time” (1 report).

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

  • Delayed Charge Time1
  • Failure of Device to Self-Test1
  • Failure to Capture1
  • Failure to Charge1
  • Failure to Deliver Shock/Stimulation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Insufficient Information1
  • Necrosis1

Recent adverse event reports

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

  • MalfunctionMay 11, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14362177 ↗
  • MalfunctionFeb 24, 2022Failure to Charge; Failure to Charge

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "DEFIB CHARGING 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 13595452 ↗
  • MalfunctionJan 18, 2022Failure to Capture; Failure to Capture

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO CAPTURE THE PATIENT'S HEART RHYTHM. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: Insufficient Information

    MAUDE report 13282769 ↗
  • DeathDec 9, 2021Failure to Deliver Shock/Stimulation; Delayed Charge Time; Failure to Deliver Shock/Stimulation; Delayed Charge Time

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE AN (B)(6) FEMALE PATIENT, THE DEVICE TOOK AN EXTENDED TIME TO CHARGE ENERGY AND FAILED TO DISCHARGE. THEY WERE UNABLE TO CONVERT THE RHYTHM FOR APPROXIMATELY 5 MIN UNTIL THE TRANSPORT AMBULANCE ARRIVED AND PLACED THE PATENT ON THEIR MONITOR. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Patient problems: Necrosis

    MAUDE report 12972074 ↗

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Sources and updates

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