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R SERIES 10000006001310012Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN, R SERIES, ALS, NELLCOR, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, NIBP, CF/USB, DMST, REFURBISHED · Class 3

All models of R SERIES (94)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847946002077), received between Jan 30, 2019 and Jan 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Energy Output Problem” (1 report).

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.

Most reported problems

Device problems

  • Energy Output Problem1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 30, 2019Energy Output Problem; Energy Output Problem

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DEFIB OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Patient Involvement

    MAUDE report 8289891 ↗

Other Automated external defibrillators (non-wearable) devices

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Sources and updates

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