X SERIES 610-0221510-01Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W/PACING, 3/5 LEAD, SPO2, NIBP, IBPTEMP, ETCO2, DMST · Class 3
All models of X SERIES (163)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847946014957), received between Feb 21, 2018 and Apr 1, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (2 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
- No Display/Image2
- Unexpected Shutdown2
- Failure of Device to Self-Test1
- Failure to Power Up1
- Reset Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 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 21739470 ↗MalfunctionApr 10, 2024Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. 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 19078293 ↗MalfunctionMay 2, 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 16856583 ↗MalfunctionNov 28, 2022Reset Problem; Reset Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE RESTART/REBOOT ITSELF MULTIPLE TIMES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15873100 ↗MalfunctionSep 19, 2022Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT AN INFANT PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. 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 15448556 ↗MalfunctionFeb 12, 2019No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S DISPLAY BLANKED OUT. 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 Consequences Or Impact To Patient
MAUDE report 8332884 ↗MalfunctionFeb 21, 2018Failure 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 7287122 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page