X SERIES 620-2211011-01Recalls & reported problems

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

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946019051), received between Dec 6, 2019 and Dec 26, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (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.

Reports received per month

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

Most reported problems

Device problems

Defibrillation/Stimulation Problem1
Failure to Power Up1
Inappropriate/Inadequate Shock/Stimulation1
No Display/Image1
Pacing Problem1
Unable to Obtain Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions4
No Patient Involvement1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 26, 2025Failure to Power Up; Failure 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 23898378 ↗
MalfunctionNov 8, 2023Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "PACER DISABLED" AND "DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091433 ↗
MalfunctionNov 1, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 48-YEAR-OLD MALE PATIENT, THE DEVICE FAILED TO DISCHARGE ON THE CORRECT WAVEFORM. 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 18046091 ↗
MalfunctionDec 9, 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 15950504 ↗
MalfunctionDec 6, 2019Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9432765 ↗

Device details

UDI-DI	`00847946019051`
Brand	X SERIES
Model	620-2211011-01
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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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.

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