BEUDAMED
    FDA Recall Open, Classified

    Class IV New Era medical laser device

    Recall: Z-0440-2021 · Initiated January 29, 2020

    Recall

    Recall Number
    Z-0440-2021
    Event Number
    86706
    Firm
    Inova Lasers LLC
    FEI Number
    3015191149
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 29, 2020
    Address
    433 5th Ave, Fl 6, New York, NY, 10016-2207

    Description

    Class IV New Era medical laser device

    Reason

    The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

    Action

    Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA.

    Distribution

    US Nationwide Distribution

    Quantity

    8 units