X SERIES 630-2231212-01Recalls & reported problems
Zoll Medical Corporation · X SERIES ADVANCED, 12 LEAD W/INTERP, PACE, SPO2, SPCO, CO2, BVM, TEMP, NIBP, CPR EXPANSION PACK, REMOTE VIEW, US · 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 resuscitation unit with monitoring and pacing options. The 61 reports mostly describe units failing to power on or pass self-tests, blank or white screens, and problems reading the ECG through electrode pads; some failed to deliver a shock when clinicians tried to use them. One death and no injuries are reported. No recalls name this device, and reports have dropped from 10 in the prior 12 months to 5 in the past year.
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
- 61
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00847946029630), received between Nov 7, 2021 and Aug 28, 2026 — classified as 1 death, 60 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (29 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 to Power Up29
- Failure of Device to Self-Test12
- No Display/Image7
- Unable to Obtain Readings7
- Defibrillation/Stimulation Problem3
- Pacing Problem3
- Failure to Deliver Shock/Stimulation2
- Unexpected Shutdown2
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Insufficient Information6
- Cardiac Arrest1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A THREE-MONTH-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND DISPLAYED A "CHECK PADS" 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 50498646 ↗MalfunctionJun 17, 2026Incorrect Interpretation of Signal; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "DEFIB FAILURE" MESSAGE. NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 25532151 ↗MalfunctionJun 10, 2026Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 25460599 ↗MalfunctionApr 15, 2026Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE 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
MAUDE report 24889370 ↗MalfunctionJan 15, 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 24081522 ↗MalfunctionSep 2, 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 22937631 ↗MalfunctionJul 10, 2025Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 56-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22467935 ↗MalfunctionJul 2, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A BIOMED TESTING, THE DEVICE'S DISPLAY WAS COMPLETELY WHITE UPON POWERING ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385205 ↗MalfunctionMay 20, 2025Pacing Problem; Unable to Obtain Readings; Defibrillation/Stimulation Problem; Pacing Problem; Unable to Obtain Readings; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB AND PACER DISABLED" MESSAGES AND WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052829 ↗MalfunctionMay 12, 2025Mechanics Altered; Mechanics Altered
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE POWERED UP IN THE INCORRECT MODE. COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003293 ↗MalfunctionFeb 18, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITH A WHITE DISPLAY AND NO CLINICAL DATA WAS READABLE. 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 21392456 ↗MalfunctionJan 21, 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. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21197073 ↗MalfunctionNov 6, 2024Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD INTERMITTENTLY 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 20622922 ↗MalfunctionNov 5, 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 20614335 ↗DeathNov 4, 2024Unable to Obtain Readings; Failure of Device to Self-Test; Unable to Obtain Readings; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 59-YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED A "DEFIB DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT TESTING, THE DEVICE FAILED SELF TEST FOR DEFIB FUNCTION.
Patient problems: Insufficient Information
MAUDE report 20603351 ↗MalfunctionSep 25, 2024Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 78-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Cardiac Arrest
MAUDE report 20299812 ↗MalfunctionSep 11, 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 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 20192191 ↗MalfunctionAug 27, 2024Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A 28-YEAR-OLD MALE PATIENT, 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 20078306 ↗MalfunctionAug 23, 2024Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR AN 87-YEAR-OLD FEMALE PATIENT, THE DEVICE DISPLAYED A "DEFIB PACE 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 20050131 ↗MalfunctionAug 7, 2024No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN WAS BLANK AND ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928840 ↗MalfunctionJul 17, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A 68-YEAR-OLD FEMALE PATIENT, THE DEVICE FAILED SELF TEST FOR DEFIB AND PACER FUNCTIONS. 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 19760037 ↗MalfunctionJul 15, 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 19739200 ↗MalfunctionJun 7, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITORING A 55-YEAR-OLD FEMALE PATIENT, THE DEVICE FAILED SELF-TEST FOR DEFIB AND PACE FUNCTIONS. 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 19483906 ↗MalfunctionMar 6, 2024Unexpected 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 18844721 ↗MalfunctionFeb 14, 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 SELF TEST FOR ECG FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18705750 ↗
Other Automated External Defibrillators (Non-Wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- 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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