BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

    Recall: Z-0689-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0689-2018
    Event ID
    79158
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Consumer Lifestyle
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    February 2, 2018
    Classification Date
    February 22, 2018
    Termination Date
    March 29, 2019
    Address
    1600 Summer St Fl 5, N/A, Stamford, CT, 06905-5125, United States

    Description

    Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

    Reason

    Device may provide inaccurate measurements.

    Code Info

    Model Numbers: SCH740 and DL8740 - All lots

    Distribution

    Domestic (2463 units) and Foreign (42678 units)

    Quantity

    45141