ZENIX 1116-111047-21-USA-0Recalls & reported problems
Zoll Medical Corporation · ZENIX, HOSPITAL FULLY LOADED CONFIGURATION · Class 3
All models of ZENIX (12)
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 00198843000346), received between Apr 14, 2026 and Aug 13, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (5 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
- Unable to Obtain Readings5
- Failure of Device to Self-Test1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Tachycardia2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING A 3 LEAD ECG ANALYSIS IN SUPRAVENTRICULAR TACHYCARDIA ON A 62-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS.COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.THIS IS THE SECOND OF A SIMILAR REPORT. THE FIRST REPORTED ON MEDWATCH 1220908-2026-03220.
Patient problems: Tachycardia
MAUDE report 50233677 ↗MalfunctionAug 13, 2026Unable to Obtain Readings
Patient problems: Tachycardia
MAUDE report 50233626 ↗MalfunctionJul 29, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071078 ↗MalfunctionJul 29, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071060 ↗MalfunctionJul 20, 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 25870232 ↗MalfunctionJul 16, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED A SECOND SET OF ELECTRODE PADS 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 25838746 ↗MalfunctionApr 14, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875308 ↗
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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.
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