M SERIESRecalls & reported problems across all models
Zoll Medical Corporation · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 162
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 0
We found 21 models of M SERIES by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2015 and Dec 22, 2021 — classified as 1 death, 161 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (41 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. 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
Most reported M SERIES problems
Device problems
- Failure to Power Up41
- Defibrillation/Stimulation Problem22
- Device Displays Incorrect Message18
- No Display/Image12
- Pacing Problem11
- Failure of Device to Self-Test10
- Failure to Discharge8
- Failure to Select Signal8
Patient problems
- No Patient Involvement141
- No Information10
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient2
- Death1
- Not Applicable1
M SERIES models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M SERIES 40010211100123010Automated external defibrillators (non-wearable)1 death75 reports
- M SERIES 40010011100103010Automated external defibrillators (non-wearable)34 reports
- M SERIES 40010211100103010Automated external defibrillators (non-wearable)18 reports
- M SERIES 40010211000103010Automated external defibrillators (non-wearable)3 reports
- M SERIES 40010211000123010Automated external defibrillators (non-wearable)3 reports
- M SERIES 40010011000103010Automated external defibrillators (non-wearable)3 reports
- M SERIES 40010011000103011Automated external defibrillators (non-wearable)3 reports
- M SERIES 40010011000123010Automated external defibrillators (non-wearable)3 reports
- M SERIES 40010211100163010Automated external defibrillators (non-wearable)3 reports
- M SERIES 40021211000123010Automated external defibrillators (non-wearable)3 reports
- M SERIES 40010211000163010Automated external defibrillators (non-wearable)2 reports
- M SERIES 60010011000123010Automated external defibrillators (non-wearable)2 reports
- M SERIES 60010011000163010Automated external defibrillators (non-wearable)2 reports
- M SERIES 40010011000163010Automated external defibrillators (non-wearable)1 report
- M SERIES 40010011100063011Automated external defibrillators (non-wearable)1 report
- M SERIES 40010511000123010Automated external defibrillators (non-wearable)1 report
- M SERIES 40021211100123010Automated external defibrillators (non-wearable)1 report
- M SERIES 40021511000123010Automated external defibrillators (non-wearable)1 report
- M SERIES 60021011000163010Automated external defibrillators (non-wearable)1 report
- M SERIES 60021211100123010Automated external defibrillators (non-wearable)1 report
- M SERIES 60021511000123010Automated external defibrillators (non-wearable)1 report
Recent M SERIES adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 13061792 ↗MalfunctionDec 20, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED TO DISCHARGE VIA EXTERNAL PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER (B)(4) FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13047724 ↗MalfunctionJun 30, 2021Failure to Deliver Shock/Stimulation; Failure 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 12096090 ↗MalfunctionJun 22, 2021Smoking; Smoking
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE SMOKED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12044376 ↗MalfunctionApr 26, 2021Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 72", "DEFIB DISABLED", AND "PACER DISABLED" MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11728683 ↗MalfunctionOct 13, 2020Output below Specifications; Output below Specifications
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S PACER OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10671688 ↗MalfunctionSep 11, 2020Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE. COMPLAINANT INDICATED THAT THEY REMOVED THE ELECTRODE PADS AND ATTACHED EXTERNAL PADDLES 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 10522633 ↗MalfunctionJul 21, 2020Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "PACER FAULT 116", "DEFIB DISABLED", AND "DEFIB FAULT 72" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10303018 ↗MalfunctionJul 14, 2020Failure 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 Patient Involvement
MAUDE report 10270801 ↗MalfunctionJul 9, 2020Failure to Power Up; Failure 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 Patient Involvement
MAUDE report 10252519 ↗MalfunctionJun 17, 2020No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10163641 ↗MalfunctionJun 9, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10134158 ↗MalfunctionJun 1, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S PACER RATE COULD NOT BE PROPERLY ADJUSTED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10106211 ↗MalfunctionMay 22, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAULT 72" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10082815 ↗MalfunctionApr 16, 2020Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DID NOT RECOGNIZE THE BATTERIES WERE INSTALLED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9967485 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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