Events

Recall of Device Recall Avent Smart Ear Thermometer, Philips Ear Thermometer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Consumer Lifestyle.

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
    79158
  • Event Risk Class
    Class 2
  • Event Number
    Z-0689-2018
  • Event Initiated Date
    2018-02-02
  • Event Date Posted
    2018-02-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161460
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Thermometer, electronic, clinical - Product Code FLL
  • Reason
    Device may provide inaccurate measurements.
  • Action
    " Philips advises users of the Device to only use the Device as directed in the instructions for use including the additional advice as per this Field Safety Notice " Philips advises users against relying on the Device as the sole basis for a decision seeking treatment and/or professional help " Users who wish to return the Devices based on the information provided in this Field Safety Notice can contact their local Philips product support representative

Device

Device Recall Avent Smart Ear Thermometer, Philips Ear Thermometer
  • Model / Serial
    Model Numbers: SCH740 and DL8740 - All lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic (2463 units) and Foreign (42678 units)
  • Product Description
    Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
  • Manufacturer
    Philips Consumer Lifestyle

Manufacturer

Philips Consumer Lifestyle
  • Manufacturer Address
    Philips Consumer Lifestyle, 1600 Summer St Fl 5, Stamford CT 06905-5125
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA