X SERIES 620-2221011-01Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, 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

Quick summary

This Zoll X Series monitor defibrillator appears in 667 adverse event reports, including 10 deaths and 1 injury. Reports mostly describe the unit showing no display, failing to power up or self-test, and shutting down unexpectedly, with some reports also mentioning cardiac arrest. There are no recalls that name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 669
Deaths reported: 10
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 669 adverse event reports that list this exact device (DI 00847946019143), received between Dec 4, 2017 and Sep 22, 2026 — classified as 10 deaths, 1 injury, 658 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (173 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Power Up173
No Display/Image170
Failure of Device to Self-Test79
Unable to Obtain Readings66
Defibrillation/Stimulation Problem33
Pacing Problem33
Unexpected Shutdown31
Failure to Deliver Shock/Stimulation30

Patient problems

No Clinical Signs, Symptoms or Conditions465
No Patient Involvement91
Insufficient Information53
No Consequences Or Impact To Patient21
No Information16
Cardiac Arrest10
Death5
Necrosis4

Recent adverse event reports

The 25 most recent of 669 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 22, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD INTERMITTENTLY NOT POWER UP.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 50853802 ↗
MalfunctionSep 15, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD 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 50775640 ↗
MalfunctionSep 14, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE TAKES APPROXIMATELY 30 SECONDS TO ONE MINUTE TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751901 ↗
MalfunctionSep 11, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE ATTACHED ELECTRODES.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732649 ↗
MalfunctionSep 10, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD INTERMITTENTLY NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50714015 ↗
MalfunctionSep 4, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616411 ↗
MalfunctionSep 1, 2026Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF-TEST FOR DEFIB FUNCTION AND PACER FUNCTIONS.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541951 ↗
MalfunctionSep 1, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541845 ↗
MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519420 ↗
MalfunctionAug 25, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430868 ↗
MalfunctionAug 14, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253330 ↗
MalfunctionJul 31, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098060 ↗
MalfunctionJul 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071696 ↗
MalfunctionJul 29, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071044 ↗
MalfunctionJul 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071040 ↗
MalfunctionJul 22, 2026Defibrillation/Stimulation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25905417 ↗
MalfunctionJul 22, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25905017 ↗
MalfunctionJul 10, 2026Reset Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE RESTART/REBOOT ITSELF MULTIPLE TIMES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25779752 ↗
MalfunctionJul 9, 2026Pacing Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "PACER FAULT" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25762036 ↗
MalfunctionJun 30, 2026Failure 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 Clinical Signs, Symptoms or Conditions
MAUDE report 25665166 ↗
MalfunctionJun 27, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT 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 Clinical Signs, Symptoms or Conditions
MAUDE report 25644820 ↗
MalfunctionJun 22, 2026Defibrillation/Stimulation Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST FOR DEFIB FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25576967 ↗
MalfunctionJun 12, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485598 ↗
MalfunctionJun 10, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25455651 ↗
MalfunctionJun 5, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF-TEST FOR DEFIB AND PACER FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411463 ↗

Device details

UDI-DI	`00847946019143`
Brand	X SERIES
Model	620-2221011-01
Company	Zoll Medical Corporation
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Feb 2, 2026

Device type (GMDN): Rechargeable professional automated external defibrillator

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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