BEUDAMED
    FDA Recall 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 · Initiated January 31, 2020

    Recall

    Recall Number
    Z-2820-2020
    Event Number
    86158
    FEI Number
    3015180076
    Product Code
    REK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 31, 2020
    Terminated
    May 2, 2023
    Address
    89 NORTH 20 Winter Sport Ln, Williston, VT, 05495-8144

    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).

    Action

    All customers who purchased an LOI prior to identification of the defect were notified of the defect electronically per the email address on record for each customer. Each affected LOI was identified by serial number per our production records. 2. The firmware upgrade was distributed to all affected customers via the electronic notification. A website link embedded in the electronic notification brings customers to an electronic form where they are asked to submit their contact information as well as the serial numbers of the LDI units they are upgrading. 3. Upon completing the form, the user is provided (via the form) another link which contains the firmware download as well as instructions for performing the upgrade. 4. For those customers who want assistance (as stated in the notification to customers), 89 North technical support can perform the upgrade for them via a remote session to the customer's computer which is interfaced to the LDI product. Please contact us with any questions or if you need any assistance completing the update and we would be happy to help you. Feel free to reach out to your normal 89 North support contact, or you can reach us at (802) 881-0302 (menu option 6) or [email protected].

    Distribution

    Worldwide

    Quantity

    188