BEUDAMED
    FDA Enforcement Class II Terminated

    IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

    Recall: Z-0661-2022 · Reported March 2, 2022

    Enforcement

    Recall Number
    Z-0661-2022
    Event ID
    89425
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2022
    Initiation Date
    December 2, 2021
    Classification Date
    February 22, 2022
    Termination Date
    September 18, 2024
    Address
    2568 Bristol Cir, Oakville, N/A, Canada

    Description

    IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

    Reason

    Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.

    Code Info

    All serial numbers

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, MI, MA, NE, OK, WV, MO, VA, CT, IN, HI, PA, CA, MD, OH, CO, SC, PR, NV, NJ, OR, LA, DC, NC and the countries of Nepal, Viet Nam, Canada, Saudi Arabia, Indonesia, Germany, Korea, Republic of

    Quantity

    221