Braun IRT6020USRecalls & reported problems
Kaz USA, Inc. · Thermometer, Braun Infrared ThermoScan Ear w/21 filters - for intermittent measurement of temperature for patients of all ages, this thermometer is used with lens filters. · 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 00328785000092), received between May 13, 2020 and May 20, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (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.
Most reported problems
Device problems
- False Negative Result2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Fever2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022False Negative Result; False Negative Result
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HERSELF, WHILE SHE WAS RECOVERING FROM COVID-19. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3.3°F LOWER THAN WAS MEASURED AT A DOCTOR'S OFFICE 30 MINUTES LATER. IT WAS ALSO STATED THAT SHE BELIEVED THAT THE UNIT MAY HAVE ALSO GIVEN LOW READINGS ON HER SON PREVIOUSLY. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND BOTH THE PATIENT AND HER CHILD ARE DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Fever
MAUDE report 14462326 ↗MalfunctionMay 13, 2020False Negative Result; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; False Negative Result; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER INFANT SON. THE DEVICE ALLEGEDLY GAVE A READING THAT WAS 3.8°F LOWER THAN WHAT WAS LATER MEASURED AT THE EMERGENCY ROOM. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Fever
MAUDE report 10052853 ↗
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- 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.