BEUDAMED
    FDA Enforcement Class II Terminated

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    Recall: Z-2820-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2820-2020
    Event ID
    86158
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    89 NORTH
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 2, 2020
    Initiation Date
    January 31, 2020
    Classification Date
    August 25, 2020
    Termination Date
    May 2, 2023
    Address
    20 Winter Sport Ln, N/A, Williston, VT, 05495-8144, United States

    Description

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    Reason

    The defect relates to firmware version lower than V02.13.00. It is controlling safety interlocks of the LDI; specifically, the potential for the LDI to enter a service mode intended for use in the factory environment only which overrides all interlocks. When this mode - "Interlock Override Mode" - is entered, the system does not cease laser emission when interlocks are opened, but rather allows emission to continue with open interlocks. The potential for this to occur is non-compliant with 21CFR 1040 .10{f )(2) and 21 CFR 1040 .10(f)(3).

    Code Info

    LDl-7, LDI-WF, LDI-NIR, LDl-6

    Distribution

    Worldwide

    Quantity

    188