BEUDAMED
    FDA Enforcement Class II Terminated

    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

    Recall: Z-1602-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1602-2020
    Event ID
    85083
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Communications
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2020
    Initiation Date
    October 11, 2019
    Classification Date
    March 27, 2020
    Termination Date
    October 18, 2022
    Address
    571 Silveron Blvd, N/A, Flower Mound, TX, 75028, United States

    Description

    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

    Reason

    The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.

    Code Info

    Serial Number Range: 091316 70016 through 083117-73252

    Distribution

    US: Nationwide OUS: Canada

    Quantity

    1415 Surgical Lights