BEUDAMED
    FDA Enforcement Class II Ongoing

    EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.

    Recall: Z-0806-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0806-2025
    Event ID
    95902
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elucent Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2025
    Initiation Date
    November 18, 2024
    Classification Date
    January 6, 2025
    Address
    7480 Flying Cloud Dr Ste 110, Eden Prairie, MN, 55344-3720, United States

    Description

    EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.

    Reason

    There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.

    Code Info

    Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION

    Distribution

    US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI

    Quantity

    283 (48 units)