R SERIES 30001000301110013Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,R SERIES, MAIN, PLUS, 3/5 LD, AC PWR, STD ECG, PACE, ETCO2, CF/USB, DMST · Class 3

All models of R SERIES (94)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Zoll R Series defibrillator is used in emergency care to deliver shocks and pace the heart. Its 256 reports often describe the unit failing to power up, failing self tests, and showing no display or readings. The reports mention 2 deaths and 2 injuries, and many were found during testing rather than on patients. 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: 260
Deaths reported: 2
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00847946017217), received between Apr 3, 2017 and Sep 30, 2026 — classified as 2 deaths, 2 injuries, 256 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (48 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

Defibrillation/Stimulation Problem48
Failure to Power Up33
No Display/Image33
Unable to Obtain Readings31
Pacing Problem22
Grounding Malfunction21
Failure of Device to Self-Test19
Failure to Deliver Shock/Stimulation17

Patient problems

No Clinical Signs, Symptoms or Conditions159
No Patient Involvement63
No Information16
Insufficient Information9
No Consequences Or Impact To Patient9
Bradycardia1
Death1
Intraoperative Cardiac Valve Injury1

Recent adverse event reports

The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 50947224 ↗
MalfunctionSep 24, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TESTING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882953 ↗
MalfunctionSep 21, 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 50841358 ↗
MalfunctionSep 18, 2026Grounding Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828611 ↗
MalfunctionSep 11, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TESTING.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731118 ↗
MalfunctionAug 21, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50378043 ↗
MalfunctionAug 14, 2026Grounding Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255033 ↗
MalfunctionAug 12, 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 50225026 ↗
MalfunctionAug 4, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE WAS UNABLE TO SWITCH MODES.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132864 ↗
MalfunctionAug 4, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE WAS UNABLE TO SWITCH MODES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130222 ↗
MalfunctionJul 31, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099903 ↗
MalfunctionJul 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071035 ↗
MalfunctionJul 16, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25838348 ↗
MalfunctionJul 15, 2026Sparking
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE ELECTRODE PADS. DURING SUBSEQUENT TESTING, TECHNICIANS REPRODUCED THE ISSUE AND ANOTHER SPARK WAS OBSERVED. 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 25826787 ↗
MalfunctionJul 10, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786179 ↗
MalfunctionJun 26, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25635312 ↗
MalfunctionJun 22, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25577142 ↗
MalfunctionMay 29, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 76" AND A "DEFIB DISABLED" MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331039 ↗
MalfunctionMay 11, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TESTING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135179 ↗
MalfunctionApr 24, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24980139 ↗
MalfunctionApr 7, 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 24798616 ↗
MalfunctionMar 31, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TESTING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741618 ↗
MalfunctionMar 30, 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 24728418 ↗
MalfunctionMar 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 24649330 ↗
MalfunctionMar 16, 2026Grounding Malfunction
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TESTING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606035 ↗

Device details

UDI-DI	`00847946017217`
Brand	R SERIES
Model	30001000301110013
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	Labeling does not contain MRI Safety Information
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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