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X SERIES 610-0121511-01Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847946014810), received between Jul 11, 2022 and Jul 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Capture” (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

  • Failure to Capture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 11, 2022Failure to Capture; Failure to Capture

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE AN 82-YEAR-OLD MALE PATIENT, THE DEVICE FAILED TO CAPTURE THE PATIENT'S HEART RHYTHM. 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 14978683 ↗

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Sources and updates

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