X SERIES 610-2221011-01Recalls & 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 and defibrillator has 501 reports that often describe it failing to power up or charge, showing no display, or shutting down unexpectedly. There are 16 deaths reported and no injuries, and many reports say no patient was involved. No recalls 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: 507
Deaths reported: 16
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 507 adverse event reports that list this exact device (DI 00847946005979), received between Jul 31, 2015 and Sep 29, 2026 — classified as 16 deaths, 491 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (121 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 Up121
No Display/Image78
Unable to Obtain Readings73
Failure of Device to Self-Test54
Reset Problem33
Defibrillation/Stimulation Problem28
Unexpected Shutdown25
Failure to Charge21

Patient problems

No Clinical Signs, Symptoms or Conditions202
No Patient Involvement163
No Information51
Insufficient Information40
No Consequences Or Impact To Patient33
Death8
Cardiac Arrest7
Necrosis4

Recent adverse event reports

The 25 most recent of 507 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 29, 2026Failure 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 50934708 ↗
MalfunctionSep 25, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899926 ↗
MalfunctionSep 21, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842953 ↗
MalfunctionSep 21, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, 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 50839959 ↗
MalfunctionSep 18, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818639 ↗
MalfunctionSep 17, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, COMPLAINANT ALLEGED THAT THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806102 ↗
MalfunctionSep 11, 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 50732024 ↗
MalfunctionSep 4, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50612981 ↗
MalfunctionAug 6, 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 50156806 ↗
MalfunctionJul 22, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25905387 ↗
MalfunctionJul 20, 2026Failure to Deliver Shock/Stimulation; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 65-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND FAILED TO DISCHARGE. 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 25873779 ↗
MalfunctionJul 20, 2026Failure to Charge
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO CHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 25873759 ↗
MalfunctionJul 14, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813083 ↗
MalfunctionJun 15, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE UNKNOWN), THE DEVICE WAS UNABLE TO DETECT THE ATTACHED 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 25510784 ↗
MalfunctionJun 15, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25503276 ↗
MalfunctionMay 13, 2026Pacing 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 & PACER FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164712 ↗
MalfunctionMay 1, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED WHILE ATTEMPTING TO MONITROR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG FAULT" 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 25055201 ↗
MalfunctionApr 9, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" 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 24835102 ↗
MalfunctionApr 3, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 24773261 ↗
MalfunctionMar 20, 2026Failure to Charge; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 52-YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED A "DEFIB CHARGING ERROR" MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649637 ↗
MalfunctionMar 19, 2026No Display/Image
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 24637361 ↗
MalfunctionMar 14, 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 FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24600414 ↗
MalfunctionMar 5, 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 24519248 ↗
MalfunctionFeb 23, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN CONTINUED 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 24422518 ↗
MalfunctionFeb 20, 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 24402184 ↗

Device details

UDI-DI	`00847946005979`
Brand	X SERIES
Model	610-2221011-01
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	Jan 30, 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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