R SERIESRecalls & reported problems across all models
Zoll Medical Corporation · 94 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8,522
- Deaths reported
- 65
- Injuries reported
- 66
- Recalls
- 0
We found 94 models of R SERIES by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 8,522 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2015 and Sep 30, 2026 — classified as 65 deaths, 66 injuries, 8,391 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (1,499 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 R SERIES problems
Device problems
- No Display/Image1,499
- Defibrillation/Stimulation Problem1,486
- Unable to Obtain Readings1,415
- Failure to Power Up1,181
- Failure to Deliver Shock/Stimulation493
- Pacing Problem481
- Failure of Device to Self-Test460
- Device Displays Incorrect Message376
Patient problems
- No Clinical Signs, Symptoms or Conditions4,538
- No Patient Involvement3,164
- Insufficient Information338
- No Information189
- No Consequences Or Impact To Patient155
- Burn(s)40
- Death27
- Necrosis21
R SERIES models
94 models, most reported first. Each model has its own page with its reports, recalls and device details.
- R SERIES 30001005201310012Automated external defibrillators (non-wearable)10 deaths1,720 reports
- R SERIES 30001000301110012Automated external defibrillators (non-wearable)10 deaths979 reports
- R SERIES 30001000001110012Automated external defibrillators (non-wearable)7 deaths907 reports
- R SERIES 30000000001110012Automated external defibrillators (non-wearable)2 deaths745 reports
- R SERIES 30001007201310012Automated external defibrillators (non-wearable)4 deaths559 reports
- R SERIES 30001003101110012Automated external defibrillators (non-wearable)4 deaths430 reports
- R SERIES 30001005201310013Automated external defibrillators (non-wearable)3 deaths312 reports
- R SERIES 30001000301110013Automated external defibrillators (non-wearable)2 deaths260 reports
- R Series 30000005201310012Automated external defibrillators (non-wearable)253 reports
- R SERIES 30001004101110012Automated external defibrillators (non-wearable)5 deaths221 reports
- R SERIES 30000001001110012Automated external defibrillators (non-wearable)2 deaths214 reports
- R SERIES 30001003101110013Automated external defibrillators (non-wearable)3 deaths152 reports
- R SERIES 30001000001110013Automated external defibrillators (non-wearable)2 deaths150 reports
- R SERIES 30001001001110012Automated external defibrillators (non-wearable)1 death136 reports
- R SERIES 30001007201310013Automated external defibrillators (non-wearable)127 reports
- R SERIES 30000005201310013Automated external defibrillators (non-wearable)126 reports
- R SERIES 30000003101110012Automated external defibrillators (non-wearable)93 reports
- R SERIES 30000000001110013Automated external defibrillators (non-wearable)1 death78 reports
- R SERIES 30001000001130012ELECTROCARDIOGRAPH72 reports
- R SERIES 30001002001110012Automated external defibrillators (non-wearable)70 reports
- R SERIES 30001004101110013Automated external defibrillators (non-wearable)68 reports
- R SERIES 30000007201310012Automated external defibrillators (non-wearable)65 reports
- R SERIES 30001009001310012Automated external defibrillators (non-wearable)55 reports
- R SERIES 10001005201310012Automated external defibrillators (non-wearable)50 reports
- R SERIES 30000000301110012Automated external defibrillators (non-wearable)1 death44 reports
- R SERIES 30000003101110013Automated external defibrillators (non-wearable)1 death37 reports
- R SERIES 30000004101110012Automated external defibrillators (non-wearable)37 reports
- R SERIES 30001006001310012Automated external defibrillators (non-wearable)1 death37 reports
- R SERIES 30000002001110012Automated external defibrillators (non-wearable)31 reports
- R SERIES 30000007201310013Automated external defibrillators (non-wearable)30 reports
- R SERIES 30000001001110013Automated external defibrillators (non-wearable)1 death29 reports
- R SERIES 10000000001110012Automated external defibrillators (non-wearable)28 reports
- R SERIES 30000000301110013Automated external defibrillators (non-wearable)28 reports
- R SERIES 30001009001310013Automated external defibrillators (non-wearable)27 reports
- R SERIES 30001009001330012Automated external defibrillators (non-wearable)1 death27 reports
- R SERIES 30000006001310012Automated external defibrillators (non-wearable)23 reports
- R SERIES 30001001001110013Automated external defibrillators (non-wearable)22 reports
- R SERIES 30000000001130012Automated external defibrillators (non-wearable)21 reports
- R SERIES 30001000001130013Automated external defibrillators (non-wearable)1 death20 reports
- R SERIES 30001009201310012Automated external defibrillators (non-wearable)17 reports
- R SERIES 30001001001130013Automated external defibrillators (non-wearable)1 death15 reports
- R SERIES 30000000001130013Automated external defibrillators (non-wearable)14 reports
- R SERIES 10000000001110013Automated external defibrillators (non-wearable)13 reports
- R SERIES 30000006201310012Automated external defibrillators (non-wearable)13 reports
- R SERIES 30000001001130013Automated external defibrillators (non-wearable)11 reports
- R SERIES 10000001001110012Automated external defibrillators (non-wearable)9 reports
- R SERIES 10000005201310012Automated external defibrillators (non-wearable)9 reports
- R SERIES 30001005201330012Automated external defibrillators (non-wearable)9 reports
- R SERIES 10000001001110013Automated external defibrillators (non-wearable)8 reports
- R SERIES 10001000001110012Automated external defibrillators (non-wearable)7 reports
- R SERIES 30000001001130012Automated external defibrillators (non-wearable)6 reports
- R SERIES 30001006201310012Automated external defibrillators (non-wearable)1 death6 reports
- R SERIES 10000005201310013Automated external defibrillators (non-wearable)5 reports
- R SERIES 30000000001010012Automated external defibrillators (non-wearable)5 reports
- R SERIES 30000004101110013Automated external defibrillators (non-wearable)5 reports
- R SERIES 30000004101130012Automated external defibrillators (non-wearable)5 reports
- R SERIES 30000005201330012Automated external defibrillators (non-wearable)5 reports
- R SERIES 10001000301110012Automated external defibrillators (non-wearable)5 reports
- R SERIES 30001002001110013ELECTROCARDIOGRAPH5 reports
- R SERIES 30000002001110013Automated external defibrillators (non-wearable)4 reports
- R SERIES 10001005201310013Automated external defibrillators (non-wearable)4 reports
- R SERIES 10001007201310012Automated external defibrillators (non-wearable)4 reports
- R SERIES 10001007201310013Automated external defibrillators (non-wearable)4 reports
- R SERIES 30001004101130012Automated external defibrillators (non-wearable)4 reports
- R SERIES 30001000001030013Automated external defibrillators (non-wearable)3 reports
- R SERIES 30001001001130012Automated external defibrillators (non-wearable)3 reports
- R SERIES 30001006201330012Automated external defibrillators (non-wearable)3 reports
- R SERIES 10000000001130013Automated external defibrillators (non-wearable)2 reports
- R SERIES 10000007201310012Automated external defibrillators (non-wearable)2 reports
- R SERIES 30000000301130012Automated external defibrillators (non-wearable)2 reports
- R SERIES 30000005201330013Automated external defibrillators (non-wearable)2 reports
- R SERIES 10001000001130012Automated external defibrillators (non-wearable)2 reports
- R SERIES 10001000001130013Automated external defibrillators (non-wearable)2 reports
- R SERIES 10001001001110012Automated external defibrillators (non-wearable)2 reports
- R SERIES 10001003101110012Automated external defibrillators (non-wearable)2 reports
- R SERIES 30001006001310013Automated external defibrillators (non-wearable)2 reports
- R SERIES 30001007201330012Automated external defibrillators (non-wearable)2 reports
- R Series 30001000001110362Automated external defibrillators (non-wearable)2 reports
- R SERIES 10000000001130012Automated external defibrillators (non-wearable)1 report
- R SERIES 10000000001010012Automated external defibrillators (non-wearable)1 report
- R SERIES 10000001001130013Automated external defibrillators (non-wearable)1 report
- R SERIES 10000003101110012Automated external defibrillators (non-wearable)1 report
- R SERIES 10000006001310012Automated external defibrillators (non-wearable)1 report
- R SERIES 30000000001030012Automated external defibrillators (non-wearable)1 report
- R SERIES 30000000001030013Automated external defibrillators (non-wearable)1 report
- R SERIES 30000001001030013Automated external defibrillators (non-wearable)1 report
- R SERIES 30000006201330012Automated external defibrillators (non-wearable)1 report
- R SERIES 10001000001110013Automated external defibrillators (non-wearable)1 report
- R SERIES 10001003101110013Automated external defibrillators (non-wearable)1 report
- R SERIES 10001006001310012Automated external defibrillators (non-wearable)1 report
- R SERIES 30001006001330012Automated external defibrillators (non-wearable)1 report
- R SERIES 30001009001210012Automated external defibrillators (non-wearable)1 report
- R SERIES 10001000301110013Automated external defibrillators (non-wearable)1 death1 report
- R SERIES 30001005201310362PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 report
Recent R SERIES adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Grounding Malfunction; Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951903 ↗MalfunctionSep 30, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951796 ↗MalfunctionSep 30, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947450 ↗MalfunctionSep 30, 2026Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB DISABLED" AND "DEFIB FAULT 76" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947428 ↗MalfunctionSep 30, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947224 ↗MalfunctionSep 29, 2026Grounding Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934778 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934767 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934520 ↗MalfunctionSep 29, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934494 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934371 ↗MalfunctionSep 28, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915047 ↗MalfunctionSep 28, 2026No 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 Clinical Signs, Symptoms or Conditions
MAUDE report 50914986 ↗MalfunctionSep 25, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO SWITCH MODES.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899962 ↗MalfunctionSep 25, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S DISPLAY BLANKED OUT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899886 ↗MalfunctionSep 24, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889312 ↗
Other Zoll Medical Corporation products
- 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
- Powerheart G5 Kit, Auto, US Eng/ESP LA2 models · 350 reports · 4 recalls
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.
How reports and recalls are matched · Editorial policy · Report an error on this page