Powerheart G5 Semi Automatic AEDRecalls & reported problems across all models
Zoll Medical Corporation · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Powerheart G5 Semi Automatic AED model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 31
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 3
We found 5 models of Powerheart G5 Semi Automatic AED by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Dec 17, 2018 and Aug 12, 2026 — classified as 1 death, 30 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (15 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Powerheart G5 Semi Automatic AED recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 13, 2025Class IIOpen, Classified
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1322-2025 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
- Feb 13, 2025Class IIOpen, Classified
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1320-2025 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
- May 31, 2024Class IIOpen, Classified
G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
Z-2324-2024 · Root cause: Use error · names 2 of these models · Recall details · FDA record ↗
Most reported Powerheart G5 Semi Automatic AED problems
Device problems
- Unable to Obtain Readings15
- Failure of Device to Self-Test6
- Failure to Deliver Shock/Stimulation2
- Failure to Power Up2
- Output Problem2
- Use of Device Problem2
- Charging Problem1
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Cardiac Arrest1
- Insufficient Information1
- Necrosis1
Powerheart G5 Semi Automatic AED models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Powerheart® G5 Semi Automatic AED G5S-01AAutomated External Defibrillators (Non-Wearable)2 recalls4 reports
- Powerheart G5 Semi Automatic AED G5S-19AAutomated External Defibrillators (Non-Wearable)1 recall3 reports
- Powerheart® G5 Semi Automatic AED G5S-01CAutomated External Defibrillators (Non-Wearable)1 recall0 reports
- Powerheart® G5 Semi Automatic AED G5S-01P1Automated External Defibrillators (Non-Wearable)1 death18 reports
- Powerheart® G5 Semi Automatic AED G5S-19P0Automated External Defibrillators (Non-Wearable)6 reports
Recent Powerheart G5 Semi Automatic AED adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "E05" ERROR MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222398 ↗MalfunctionAug 5, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140788 ↗MalfunctionMay 7, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "SELF TEST FAILURE FOR Z SAMPLE < THRESHOLD" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116364 ↗MalfunctionOct 6, 2025Unable to Obtain Readings; Unable 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 23228438 ↗MalfunctionNov 15, 2024Unable to Obtain Readings; Unable 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 20694034 ↗MalfunctionSep 18, 2024Unable to Obtain Readings; Unable 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 20247303 ↗MalfunctionSep 16, 2024Unable to Obtain Readings; Unable 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 20231205 ↗MalfunctionApr 10, 2024Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A RED "X" INDICATOR. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081460 ↗MalfunctionApr 10, 2024Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING A FUNCTIONAL TESTING, THE DEVICE DISPLAYED A RED "X" INDICATOR. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19077934 ↗MalfunctionJan 25, 2024Unable to Obtain Readings; Failure of Device to Self-Test; Unable to Obtain Readings; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE AND WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18578826 ↗MalfunctionAug 14, 2023Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED 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 17541875 ↗MalfunctionAug 11, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED 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 17513097 ↗MalfunctionJul 7, 2023Unable to Obtain Readings; Unable 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 17282703 ↗MalfunctionJul 7, 2023Unable to Obtain Readings; Unable 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 17281985 ↗MalfunctionJul 7, 2023Unable to Obtain Readings; Unable 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 17281877 ↗
Other Zoll Medical Corporation products
- R SERIES94 models · 8,522 reports
- X SERIES163 models · 6,915 reports
- AED PLUS30 models · 1,966 reports · 1 recall
- Z Vent6 models · 1,204 reports · 1 recall
- Model EMV+ Vent, Army, MRI3 models · 964 reports
- E SERIES160 models · 833 reports
- ONESTEP8 models · 586 reports
- M SERIES BIPHASIC59 models · 572 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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