BEUDAMED
    FDA Recall Open, Classified

    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

    Recall: Z-2102-2025 · Initiated June 17, 2025

    Recall

    Recall Number
    Z-2102-2025
    Event Number
    97121
    Firm
    Intersurgical Inc
    FEI Number
    1000120301
    Product Code
    CCW
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    June 17, 2025
    Posted
    July 11, 2025
    Address
    5010 Campuswood Dr, Ste 102, East Syracuse, NY, 13057-1561

    Description

    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

    Reason

    Potential for faulty devices as a result of depleted batteries.

    Action

    Intersurgical notified consignees and account executives via email on 06/17/2025. The notification instructed consignees and account executives to immediately discontinue use and quarantine any affected stock on hand, notify customers if affected units have been further distributed, and contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number and return label to return all affected units. Also, they were instructed to complete and return the Customer Product Recall Acknowledgement Form.

    Distribution

    US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.

    Quantity

    2,152 pieces