Filac 504003Recalls & reported problems
Cardinal Health, Inc. · 3000 EZA Electronic Thermometer,Oral/Axillary Complete System with 4 foot (1.2 m) Cord · Class 2
Data updated Oct 16, 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 10884521104037), received between Sep 27, 2018 and Sep 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (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 16, 2026.
Most reported problems
Device problems
- Thermal Decomposition of Device1
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.
MalfunctionSep 27, 2018Thermal Decomposition of Device; Thermal Decomposition of Device
THE CUSTOMER REPORTED THERE WAS A SPARK AND SMOKE EMITTED FROM THE UNIT AND YOU CAN CLEARLY SMELL A BURNT SMELL FROM INSIDE THE UNIT. THE UNIT WAS NOT BEING USED ON A PATIENT AT THE TIME THE USER HAD JUST CHANGED OVER THE BATTERIES WHEN THE PROBLEM OCCURRED.
Patient problems: No Patient Involvement
MAUDE report 7916008 ↗
Other Thermometer, electronic, clinical devices
- Welch Allyn, Inc. 901054Welch Allyn, Inc. · Thermometer, electronic, clinical1 recall221 reports
- Welch Allyn, Inc. 901054Welch Allyn, Inc. · Thermometer, electronic, clinical2 recalls13 reports
- NA B105 VSP3.0 Patient MonitorGE Medical Systems Information Technologies, Inc. · Thermometer, electronic, clinical2 recalls0 reports
- Medline MDSTH1002Medline Industries, Inc. · Thermometer, electronic, clinical65 reports
- Mon-a-Therm 90050Covidien LP · Thermometer, electronic, clinical1 recall3 reports
- Mon-a-Therm 90044Covidien LP · Thermometer, electronic, clinical1 recall2 reports
- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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