BEUDAMED
    FDA Recall Open, Classified

    Non-ablative Fractional Laser Systems, Model: WFB-01

    Recall: Z-0555-2025 · Initiated August 23, 2024

    Recall

    Recall Number
    Z-0555-2025
    Event Number
    95831
    Firm
    WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China
    FEI Number
    3014310779
    Product Code
    ONG
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 23, 2024
    Posted
    December 5, 2024

    Description

    Non-ablative Fractional Laser Systems, Model: WFB-01

    Reason

    Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)

    Action

    The firm sent a notification letter to the relevant distribution on June 6, 2024. Products sold before August 23, 2022, will require a software version upgrade to F1-B-1.1.012 or Higher.

    Distribution

    Worldwide Distribution