BEUDAMED
    FDA Recall Terminated

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    Recall: Z-2046-2013 · Initiated August 1, 2013

    Recall

    Recall Number
    Z-2046-2013
    Event Number
    65865
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HKI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 1, 2013
    Posted
    August 23, 2013
    Terminated
    February 25, 2014
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    Reason

    Under certain circumstances, the Left eye image may be saved as the Right eye image.

    Action

    "Medical Device Correction Notification" letters dated August 5, 2013 were sent to consignees through their US contracted distributor - Marco Opthalmic. The letter described the product issue and provided information on the correction. Customers can contact 800-223-9044 for questions.

    Distribution

    Nationwide US distribution only.

    Quantity

    86