BEUDAMED
    FDA Enforcement Class II Ongoing

    Zenition 50, Model #718096

    Recall: Z-0647-2022 · Reported February 23, 2022

    Enforcement

    Recall Number
    Z-0647-2022
    Event ID
    89437
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 23, 2022
    Initiation Date
    December 2, 2021
    Classification Date
    February 17, 2022
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Zenition 50, Model #718096

    Reason

    Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

    Code Info

    Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

    Distribution

    Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.

    Quantity

    16 US; 76 ROW