X SERIES 610-2211511-01Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR, W/PACING, NELLCOR, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, 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 and defibrillator with pacing functions. The 26 reports mostly describe failed self-tests, pacing problems, failure to power on, unexpected shutdowns, and display problems; no deaths or injuries were reported. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00847946005917), received between Aug 18, 2015 and Aug 28, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (6 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
Most reported problems
Device problems
- Failure of Device to Self-Test6
- Failure to Power Up4
- Pacing Problem4
- No Display/Image3
- Reset Problem3
- Unexpected Shutdown3
- Device Displays Incorrect Message2
- Defibrillation/Stimulation Problem1
Patient problems
- No Patient Involvement15
- No Clinical Signs, Symptoms or Conditions7
- No Information4
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498298 ↗MalfunctionApr 14, 2025Reset Problem; Reset Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "INTERNAL ERROR OCCURRED - SYSTEM RESET REQUIRED" 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 21834728 ↗MalfunctionMar 27, 2024Failure of Device to Self-Test; Output Problem; Failure of Device to Self-Test; Output Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF-TEST FOR DEFIB FUNCTION AND THE PACER OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986010 ↗MalfunctionJun 14, 2023Failure 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 17126098 ↗MalfunctionMar 23, 2022Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 13861942 ↗MalfunctionAug 31, 2021No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DISPLAY WAS NOT LEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12393127 ↗MalfunctionAug 14, 2021Failure 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 12322210 ↗MalfunctionDec 23, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO PACE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 11066833 ↗MalfunctionJun 10, 2020Failure 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 PACER AND ECG FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10138808 ↗MalfunctionFeb 19, 2020Reset Problem; Reset Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD REBOOT/RESTART ITSELF. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9728254 ↗MalfunctionNov 11, 2019Reset Problem; Reset Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE RESTART/REBOOT ITSELF. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9306075 ↗MalfunctionAug 9, 2019Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT AN (B)(6) YEAR OLD FEMALE PATIENT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-02220 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.
Patient problems: No Information
MAUDE report 8880620 ↗MalfunctionAug 9, 2019Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD FEMALE PATIENT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-02221 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.
Patient problems: No Information
MAUDE report 8880619 ↗MalfunctionAug 5, 2019Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 Patient Involvement
MAUDE report 8860637 ↗MalfunctionMar 25, 2019Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "DEFIB DISABLED" AND "PACER DISABLED" MESSAGES. 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 Information
MAUDE report 8449386 ↗MalfunctionFeb 8, 2019Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8323413 ↗MalfunctionOct 10, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT FULLY POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7952006 ↗MalfunctionSep 20, 2018Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 Patient Involvement
MAUDE report 7893106 ↗MalfunctionAug 31, 2018Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "PACER PAD CONNECTION FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7837145 ↗MalfunctionJul 19, 2018Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST FOR PACER FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7703001 ↗MalfunctionMay 9, 2018Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST FUNCTION FOR ECG. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7500849 ↗MalfunctionMay 4, 2018Loss of Power; Device Displays Incorrect Message; Loss of Power; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN AND DISPLAYED AN "INVALID FAULT CODE" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7488614 ↗MalfunctionAug 16, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ECG MONITORING DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6798073 ↗MalfunctionMay 2, 2017Failure 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 Patient Involvement
MAUDE report 6538576 ↗MalfunctionMar 13, 2017No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE'S DISPLAY BLANKED OUT. COMPLAINANT INDICATED THAT THE DEVICE'S DISPLAY RETURNED AND THEY CONTINUED TO TREAT THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 6400884 ↗
Other Automated external defibrillators (non-wearable) devices
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- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
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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