Powerheart G5 Kit, Auto, US Eng/ESP LA G5A-80CRecalls & reported problems
Zoll Medical Corporation · Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads with CPR feedback device and Battery · Class 3
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Zoll Powerheart G5 is an automated external defibrillator with a battery and pads. Many of its 188 reports describe the unit being unable to obtain readings, failing its self-test, or not powering up. There are no injuries and 2 death reports. There are 2 open recalls, both about units failing self-test after prolonged exposure to extreme temperature or humidity.
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
- 207
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 00812394021208), received between Dec 29, 2023 and Sep 29, 2026 — classified as 2 deaths, 205 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (70 reports).
2 FDA recall records name this device's identifier, 2 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 13, 2025Open, Classified
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1319-2025 · Root cause: Unknown/Undetermined by firm · FDA record ↗
- Feb 13, 2025Open, Classified
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1318-2025 · Root cause: Unknown/Undetermined by firm · FDA record ↗
Most reported problems
Device problems
- Unable to Obtain Readings70
- Failure of Device to Self-Test48
- Failure to Power Up25
- Use of Device Problem21
- Defibrillation/Stimulation Problem17
- Failure to Charge15
- Incorrect Interpretation of Signal10
- Output Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions195
- Insufficient Information7
- Intraoperative Cardiac Valve Injury2
- Burn(s)1
- Cardiac Arrest1
- Ventricular Fibrillation1
Recent adverse event reports
The 25 most recent of 207 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934155 ↗MalfunctionSep 28, 2026Use of Device Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED ERROR CODE "E05" OBSERVED IN THE ERROR LOG.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914895 ↗MalfunctionSep 25, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899953 ↗MalfunctionSep 24, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882723 ↗MalfunctionSep 23, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872011 ↗MalfunctionSep 23, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867969 ↗MalfunctionSep 22, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED AN "ERROR E05 OBSERVED IN THE LOG" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853931 ↗MalfunctionSep 18, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818156 ↗MalfunctionSep 18, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817078 ↗MalfunctionSep 15, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "SELF-TEST FAILURE FOR P/S V OUT OF RANGE" ERROR MESSAGE.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772256 ↗MalfunctionSep 15, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772131 ↗MalfunctionSep 15, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772091 ↗MalfunctionSep 14, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755871 ↗MalfunctionSep 14, 2026Defibrillation/Stimulation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753168 ↗MalfunctionSep 14, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753140 ↗MalfunctionSep 11, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50730750 ↗MalfunctionSep 9, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690612 ↗MalfunctionSep 8, 2026Unable to Obtain Readings; Incorrect Interpretation of Signal
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE PROMPTED "NO SHOCK ADVISED" FOR A RHYTHM CLINICIANS BELIEVED TO BE SHOCKABLE AND DID NOT DETECT THE ATTACHED ELECTRODE PADS.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 50669412 ↗MalfunctionSep 4, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616440 ↗MalfunctionSep 2, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567517 ↗MalfunctionSep 1, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543976 ↗MalfunctionAug 28, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497854 ↗MalfunctionAug 25, 2026Failure to Charge; Defibrillation/Stimulation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50432446 ↗MalfunctionAug 21, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379344 ↗MalfunctionAug 14, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255026 ↗
Other Automated External Defibrillators (Non-Wearable) devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.