BEUDAMED
    FDA Recall Terminated

    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.

    Recall: Z-0811-2016 · Initiated April 13, 2015

    Recall

    Recall Number
    Z-0811-2016
    Event Number
    71008
    Firm
    Verathon, Inc.
    FEI Number
    3022472
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 13, 2015
    Posted
    July 13, 2015
    Terminated
    October 26, 2016
    Address
    20001 N Creek Pkwy, Bothell, WA, 98011-8218

    Description

    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.

    Reason

    Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.

    Action

    Verathon sent an Urgent Medical Device Safety Alert letter dated April 13, 2015 and Safety Alert Reply Form to their consignees on April 17, 2015 Users are informed that Verathon implemented a Safety Alert regarding updates to the following Operations and Maintenance Manuals (OMM): " GVL Operations and Maintenance Manual: 0900-1204-08-60 " AVL Operations and Maintenance Manual: 0900-4200-02-60 For a copy of the most recent GVL or AVL Operations and Maintenance Manual, please visit http://verathon.com/support. If you have any questions regarding the Operations and Maintenance Manuals revisions noted above, please contact your Verathon representative or Verathon Customer Care at 800.331.2313 or 425.867.1348. You may also email [email protected]. PLEASE NOTE: NO ADDITIONAL ACTIONS NEED TO BE TAKEN.

    Distribution

    Worldwide Distribution.

    Quantity

    total 9088 units ( 5786 units in the US and 3302 units International)