Filac 505003Recalls & reported problems

Cardinal Health, Inc. · 3000 ADA 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 10884521104051), received between Sep 27, 2017 and Sep 27, 2017 — classified as 1 malfunction.

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

Appropriate Device Problem Term/Code Not Available1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionSep 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE UNIT WAS SENT TO A SERVICE CENTER FOR REPAIR. UPON TRIAGE, A TECHNICIAN FOUND A BURNED TRACK ON THE KEYBOARD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6899671 ↗

Device details

UDI-DI	`10884521104051`
Brand	Filac
Model	505003
Company	Cardinal Health, Inc.
Product code	FLL · Thermometer, electronic, clinical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 31, 2025

Device type (GMDN): Intermittent electronic patient thermometer

A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.