BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor

    Recall: Z-2021-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-2021-2024
    Event ID
    94547
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Verathon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2024
    Initiation Date
    April 29, 2024
    Classification Date
    June 4, 2024
    Address
    20001 N Creek Pkwy, N/A, Bothell, WA, 98011-8218, United States

    Description

    Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor

    Reason

    Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

    Code Info

    Software Version: v1.9 and earlier/ UDI: UDI/DI: 00879123006639

    Distribution

    US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK ON OR PA QLD RI SC SD TN TX UT VA VIC WA WI WV WY OUS: Hong Kong, Indonesia, Saudi Arabia

    Quantity

    2568 devices