X SERIES 600-2231011-01Recalls & reported problems
Zoll Medical Corporation · Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK AND ETCO2, DMST · Class 2
All models of X SERIES (163)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847946012809), received between May 18, 2017 and Aug 20, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (2 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.
Most reported problems
Device problems
- Failure of Device to Self-Test2
- Reset Problem1
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2018Reset Problem; Reset Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE RESTART/REBOOT ITSELF. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7796683 ↗MalfunctionJul 13, 2017Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST FOR DEFIB FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6711106 ↗MalfunctionMay 18, 2017Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST FOR DEFIB. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6576718 ↗
Other COMPUTER, BLOOD-PRESSURE devices
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- AVVIGO™+ H7492493121C0Boston Scientific Corporation · COMPUTER, BLOOD-PRESSURE1 recall0 reports
- SureSigns VS2+ 863278Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE40 reports
- SureSigns VSi 863276Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE21 reports
- M SERIES CCT 40021911100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE17 reports
- SureSigns VS2+ 863279Philips Medical Systems Hsg · COMPUTER, BLOOD-PRESSURE16 reports
- M SERIES CCT 40010911100124010Zoll Medical Corporation · COMPUTER, BLOOD-PRESSURE8 reports
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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