Events

Recall of PHILIPS AVENT SMART EAR THERMOMETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25781
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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.

Device

PHILIPS AVENT SMART EAR THERMOMETER
  • Model / Serial
    Model Catalog: SCH740 (Lot serial: >1000 NUMBERS CONTACT MFG)
  • Product Description
    PHILIPS AVENT SMART EAR THERMOMETER
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC