DeRoyal M1024229VYRecalls & reported problems

Deroyal Industries, Inc. · General Purpose Temperature Probe · Class 2

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756984072), received between Aug 9, 2024 and Aug 9, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Incorrect Interpretation of Signal2
Increased Sensitivity2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 9, 2024Incorrect Interpretation of Signal; Increased Sensitivity; Incorrect Interpretation of Signal; Increased Sensitivity
A USER FACILITY REPORTED "THE TEMPERATURE PROBE IS NOT SHOWING THE RIGHT TEMPERATURE AND IS VERY SENSITIVE WHEN MOVING THE PROBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950071 ↗
MalfunctionAug 9, 2024Incorrect Interpretation of Signal; Increased Sensitivity; Incorrect Interpretation of Signal; Increased Sensitivity
A USER FACILITY REPORTED "THE TEMPERATURE PROBE IS NOT SHOWING THE RIGHT TEMPERATURE AND IS VERY SENSITIVE WHEN MOVING THE PROBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950015 ↗

Device details

UDI-DI	`00749756984072`
Brand	DeRoyal
Model	M1024229VY
Company	Deroyal Industries, Inc.
Product code	FLL · Thermometer, electronic, clinical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 17, 2021

Device type (GMDN): General-purpose patient temperature probe, single-use

A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Other Thermometer, electronic, clinical devices

Welch Allyn, Inc. 901054
Welch Allyn, Inc. · Thermometer, electronic, clinical
1 recall221 reports
Welch Allyn, Inc. 901054
Welch Allyn, Inc. · Thermometer, electronic, clinical
2 recalls13 reports
NA B105 VSP3.0 Patient Monitor
GE Medical Systems Information Technologies, Inc. · Thermometer, electronic, clinical
2 recalls0 reports
Medline MDSTH1002
Medline Industries, Inc. · Thermometer, electronic, clinical
65 reports
Mon-a-Therm 90050
Covidien LP · Thermometer, electronic, clinical
1 recall3 reports
Mon-a-Therm 90044
Covidien LP · Thermometer, electronic, clinical
1 recall2 reports
Temperature Probes Esophageal/Rectal Temperature Probe
Philips Medical Systems Hsg · Thermometer, electronic, clinical
1 recall1 report
CARESCAPE B450 MBA313
GE Healthcare Finland Oy · Thermometer, electronic, clinical
1 recall1 report

All Thermometer, electronic, clinical devices →

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