BEUDAMED
    FDA Recall Open, Classified

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    Recall: Z-1971-2023 · Initiated March 16, 2023

    Recall

    Recall Number
    Z-1971-2023
    Event Number
    92532
    Firm
    Ellex Medical Pty Ltd.
    FEI Number
    3002806902
    Product Code
    HQF
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 16, 2023
    Posted
    June 27, 2023
    Address
    3-4 Second Ave, Mawson Lakes Australia

    Description

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    Reason

    When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.

    Action

    Ellex Safety Bulletin is the customer notification letter. Ellex will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Ellex-Lumibird representative or email us on [email protected].

    Distribution

    US nationwide/ Worldwide Distribution

    Quantity

    57 systems in total (6 units shipped to United States)