Philips AVENT Smart Ear Thermometer (2018-01-25)

Starting date:
January 25, 2018
Posting date:
February 22, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66026

Affected products

PHILIPS AVENT SMART EAR THERMOMETER

Reason

There is a possibility that a lay user obtains a body temperature value of a febrile patient that is lower than actual, just missing the fever threshold.
The lay user might not recognize a false negative fever measurement as inaccurate and base the decision not to seek help or not to treat solely on the reading of the device, ignoring other possible symptoms of disease. This may lead to delayed treatment, which might contribute to an injury or aggravation of the underlying disease.
Instructions for use instruct users of the Ear Thermometer SCH740 on the way to take measurements, including how to direct the device, and keep the sensor tip clean, which are most crucial aspects for obtaining a proper temperature reading. The users are cautioned that the values are for reference only, and not a substitute for professional advice.

Affected products

PHILIPS AVENT SMART EAR THERMOMETER

Lot or serial number

More than 1000 numbers, contact manufacturer.

Model or catalog number

SCH740

Companies
Manufacturer
Philips Consumer Lifestyle B.V.
Tussendiepen 4
Drachten
9206
NETHERLANDS