ZENIXRecalls & reported problems across all models
Zoll Medical Corporation · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 87
- Deaths reported
- 3
- Injuries reported
- 0
- Recalls
- 0
We found 12 models of ZENIX by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2026 and Sep 30, 2026 — classified as 3 deaths, 84 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (26 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
Reports received per month, all models
Most reported ZENIX problems
Device problems
- Unable to Obtain Readings26
- Unexpected Shutdown17
- Failure of Device to Self-Test15
- No Display/Image7
- Failure to Power Up5
- Grounding Malfunction5
- Activation Problem2
- Defibrillation/Stimulation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- Insufficient Information21
- Tachycardia2
- Cardiac Arrest1
ZENIX models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ZENIX 1116-321B4B-11-USA-0Automated external defibrillators (non-wearable)2 deaths42 reports
- ZENIX 1116-121B7B-11-USA-0Automated external defibrillators (non-wearable)9 reports
- ZENIX 1116-210047-21-USA-0Automated External Defibrillators (Non-Wearable)9 reports
- ZENIX 1116-111047-21-USA-0Automated External Defibrillators (Non-Wearable)7 reports
- ZENIX 8116-12-41-01300-00-USAAutomated external defibrillators (non-wearable)4 reports
- ZENIX 1116-321B7B-11-USA-0Automated external defibrillators (non-wearable)4 reports
- ZENIX 1116-321B6B-11-USA-0Automated external defibrillators (non-wearable)4 reports
- ZENIX 1116-121B4B-11-USA-0Automated External Defibrillators (Non-Wearable)1 death3 reports
- ZENIX 1116-211047-21-USA-0Automated External Defibrillators (Non-Wearable)2 reports
- ZENIX 1116-111077-21-USA-0Automated External Defibrillators (Non-Wearable)1 report
- ZENIX 1116-211077-21-USA-0Automated External Defibrillators (Non-Wearable)1 report
- ZENIX 1116-421B7B-11-USA-0Automated external defibrillators (non-wearable)1 report
Recent ZENIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947590 ↗MalfunctionSep 30, 2026Grounding Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947581 ↗MalfunctionSep 30, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED SELF TEST.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947562 ↗MalfunctionSep 29, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, 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 50933619 ↗MalfunctionSep 28, 2026Failure 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 50915859 ↗MalfunctionSep 24, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50883671 ↗MalfunctionSep 24, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50883641 ↗MalfunctionSep 24, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50883391 ↗MalfunctionSep 22, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO SHOCK A 45-YEAR-OLD MALE PATIENT, 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 50853748 ↗MalfunctionSep 21, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO CONNECT TO THE MULTIFUNCTION CABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842889 ↗MalfunctionSep 18, 2026Pacing Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAILURE" AND UNSPECIFIED "PACER FAULT" MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820529 ↗MalfunctionSep 17, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED BLOOD PRESSURE CUFF SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50806061 ↗MalfunctionSep 17, 2026Unexpected Shutdown; Activation Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE SHOWED NO RESPONSE TO USER INPUT ON TOUCHSCREEN AND INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50804662 ↗MalfunctionSep 11, 2026Overheating of Device; Unable to Obtain Readings; Protective Measures Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS, THE NIBP DID NOT FUNCTION AND THE DEVICE OVERHEATED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736847 ↗MalfunctionSep 10, 2026Activation Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DID NOT RESPOND TO USER INPUT ON TOUCHSCREEN.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50714050 ↗
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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