X SERIES 620-2231511-01Recalls & 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 · 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 has 97 adverse event reports describing screens going dark, units failing to power on or pass self-tests, defibrillation energy not delivering, and unexpected shutdowns; many occurred during testing with no patient involved. There is one death and no injuries. 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: 96
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00847946019297), received between Mar 26, 2018 and Sep 9, 2026 — classified as 1 death, 95 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (27 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

No Display/Image27
Failure to Power Up23
Unable to Obtain Readings17
Defibrillation/Stimulation Problem9
Failure of Device to Self-Test9
Unexpected Shutdown7
Failure to Deliver Shock/Stimulation3
Pacing Problem3

Patient problems

No Clinical Signs, Symptoms or Conditions75
Insufficient Information13
No Patient Involvement5
Cardiac Arrest1
Necrosis1
No Consequences Or Impact To Patient1
No Information1
Ventricular Fibrillation1

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 9, 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 50689936 ↗
MalfunctionAug 20, 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 50345704 ↗
MalfunctionAug 17, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED SELF-TEST FOR DEFIB FUNCTION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50275298 ↗
MalfunctionAug 14, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254857 ↗
MalfunctionAug 14, 2026No Display/Image
Patient problems: Insufficient Information
MAUDE report 50253309 ↗
MalfunctionAug 12, 2026No Display/Image; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN AND AN UNSPECIFIED DISPLAY PROBLEM. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50219658 ↗
MalfunctionMay 8, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST FOR DEFIB. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130964 ↗
MalfunctionApr 13, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED 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 24858386 ↗
MalfunctionMar 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 24716366 ↗
MalfunctionJan 12, 2026Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE 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; Ventricular Fibrillation
MAUDE report 24036125 ↗
MalfunctionJan 7, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED SELF-TEST FOR DEFIB & PACER FUNCTIONS. 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 23991821 ↗
MalfunctionJan 7, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "DEFIB FAILURE" MESSAGE. NO FURTHER INFORMATION WAS AVAILABLE. 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 23991020 ↗
MalfunctionDec 26, 2025Failure to Charge; Failure to Charge
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DELAYED CHARGING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898343 ↗
MalfunctionNov 17, 2025Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569355 ↗
MalfunctionOct 27, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICES 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 23391747 ↗
MalfunctionOct 22, 2025Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED SELF TEST FOR ECG FUNCTION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23361104 ↗
MalfunctionJul 23, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED 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 22576357 ↗
MalfunctionJul 14, 2025Failure to Power Up; Failure 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 22493522 ↗
MalfunctionJul 3, 2025Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD 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 22395454 ↗
MalfunctionJun 24, 2025Activation Problem; Activation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DID NOT RESPOND TO THE FRONT PANEL CONTROLS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318046 ↗
MalfunctionJun 16, 2025Failure to Analyze Signal; Failure to Analyze Signal
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN). THE DEVICE WAS UNABLE TO ANALYZE THE PATIENT RHYTHM. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22216451 ↗
MalfunctionJun 13, 2025Unexpected Shutdown; Unexpected 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 22202387 ↗
MalfunctionMay 22, 2025Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A " DEFIB PACER DEVICE FAILURE" MESSAGE. 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 22069091 ↗
MalfunctionJan 13, 2025No Display/Image; No 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 21137893 ↗
MalfunctionDec 23, 2024No Display/Image; No 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 21000821 ↗

Device details

UDI-DI	`00847946019297`
Brand	X SERIES
Model	620-2231511-01
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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