BEUDAMED
    FDA Recall 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 · Initiated June 5, 2020

    Recall

    Recall Number
    Z-2476-2020
    Event Number
    85705
    Firm
    Verathon, Inc.
    FEI Number
    3022472
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 5, 2020
    Posted
    July 10, 2020
    Terminated
    April 22, 2024
    Address
    20001 N Creek Pkwy, Bothell, WA, 98011-8218

    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.

    Action

    On 06/05/20, Field Safety Notice/ URGENT:MEDICAL DEVICE RECALL notices were sent to customers. Customers were asked to do the following: - Review the information contained within this Field Safety Notice with all staff members who should be aware of the contents of the Field Safety Notice. - Discontinue use of all affected cables. - When replacements are received, destroy or return all affected cables in your possession. - Complete and return the recall response form. Customers with additional questions are encouraged to contact Customer Care agent support Monday through Friday from 6:00am to 4:00pm Pacific Time for the United States at (800) 331-2313 or email [email protected]

    Distribution

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

    Quantity

    437