X SERIES 620-0211011-01Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, PACING, NIBP, SPO2, 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 defibrillator is a portable monitor/defibrillator used in hospitals and by EMS teams. The 30 reports mostly describe the unit failing its routine self-check, not powering up, or showing a blank white screen during shift checks and biomedical testing. There are no deaths 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: 30
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00847946018627), received between Jun 16, 2020 and Apr 14, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (9 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 of Device to Self-Test9
Failure to Power Up8
No Display/Image5
Defibrillation/Stimulation Problem2
Unable to Obtain Readings2
Electrical Shorting1
Failure to Deliver Shock/Stimulation1
Pacing Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions24
No Patient Involvement4
Insufficient Information2

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 14, 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 24875216 ↗
MalfunctionApr 7, 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 24799885 ↗
MalfunctionMar 19, 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 24643387 ↗
MalfunctionFeb 17, 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 24369774 ↗
MalfunctionDec 1, 2025Failure of Device to Self-Test; 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 23680917 ↗
MalfunctionOct 23, 2025Electrical Shorting; Electrical Shorting
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE PROMPTED A "SHORT DETECTED" MESSAGE COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367289 ↗
MalfunctionAug 25, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22885452 ↗
MalfunctionJul 2, 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 22385217 ↗
MalfunctionJun 12, 2025Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE DISPLAYED A "DEFIB PACER DEVICE FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22193011 ↗
MalfunctionApr 29, 2025Failure of Device to Self-Test; Failure 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 21927714 ↗
MalfunctionApr 18, 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 21865865 ↗
MalfunctionMar 20, 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 AT THE TIME OF THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21654717 ↗
MalfunctionJun 11, 2024Failure 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 19510539 ↗
MalfunctionMay 29, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED THE 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 19415162 ↗
MalfunctionJan 31, 2024Failure 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 18613878 ↗
MalfunctionMar 22, 2023No 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 16590498 ↗
MalfunctionMar 1, 2023No Display/Image; No 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: Insufficient Information
MAUDE report 16461818 ↗
MalfunctionNov 14, 2022Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND DISPLAYED AN UNKNOWN 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 15788475 ↗
MalfunctionNov 4, 2022Failure to Power Up; Failure 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 15735197 ↗
MalfunctionSep 6, 2022Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA PADS. 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 15364245 ↗
MalfunctionAug 3, 2022No 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 15158517 ↗
MalfunctionJun 14, 2022Failure 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 14684309 ↗
MalfunctionJun 13, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676829 ↗
MalfunctionApr 7, 2022Self-Activation or Keying; Self-Activation or Keying
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE SELF DISCHARGED. 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 14044815 ↗
MalfunctionMar 24, 2022Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF-TEST FOR DEFIB FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13891524 ↗

Device details

UDI-DI	`00847946018627`
Brand	X SERIES
Model	620-0211011-01
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.

Other Automated external defibrillators (non-wearable) devices

NA 861290
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
12 deaths5,167 reports
NA 861288
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
21 deaths5,015 reports
NA 861289
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
7 deaths3,385 reports
R SERIES 30001005201310012
Zoll Medical Corporation · Automated external defibrillators (non-wearable)
10 deaths1,720 reports
PHILIPS HeartStart FRx
Philips Electronics North America Corporation · Automated external defibrillators (non-wearable)
26 deaths1,586 reports
LIFEPAK CR2 99512
Physio-Control, Inc. · Automated external defibrillators (non-wearable)
8 deaths1,502 reports
Lifeline Configuration DDU-100A
Defibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)
1 death1,285 reports
PHILIPS HeartStart FR3
Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)
10 deaths1,188 reports

All Automated external defibrillators (non-wearable) devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page