BEUDAMED
    FDA Enforcement Class I Terminated

    GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endoscopes, in conjunction with ancillary equipment, for endoscopic procedures.

    Recall: Z-2476-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2476-2020
    Event ID
    85705
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Verathon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 5, 2020
    Classification Date
    July 9, 2020
    Termination Date
    April 22, 2024
    Address
    20001 N Creek Pkwy, Bothell, WA, 98011-8218, United States

    Description

    GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endoscopes, in conjunction with ancillary equipment, for endoscopic procedures.

    Reason

    When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization interruption, loss of live image/blank screen, no cameras connected monitor warning, may present risk to patients, in which time to intubation is more critical.

    Code Info

    All serial numbers

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom.

    Quantity

    437