Filac 504000Recalls & reported problems
Cardinal Health, Inc. · 3000 EZ Electronic Thermometer,Oral/Axillary Complete System with 4 foot (1.2 m) Cord · Class 2
- 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 20884521008455), received between Aug 16, 2017 and Aug 16, 2017 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Thermal Decomposition of Device1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2017Thermal Decomposition of Device; Thermal Decomposition of Device
THE UNIT WAS SENT TO A SERVICE CENTER FOR REPAIR. UPON TRIAGE, A TECHNICIAN FOUND THE PCB TO HAVE THERMAL DAMAGE ON THE RIGHT BOTTOM AREA. THE PINS WERE BURNT AND A CAVITY WAS SEEN, FILLED WITH BLACK RESIDUE. BLACK RESIDUE WAS ALSO OBSERVED ON THE COMPONENTS SURROUNDING THE PINS AND FUSE. IT WAS UNCLEAR IF THESE COMPONENTS SUFFERED THERMAL DAMAGE.
Patient problems: No Information
MAUDE report 6798564 ↗
Other Thermometer, electronic, clinical devices
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- 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
- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.