BEUDAMED
    FDA Recall Terminated

    Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.

    Recall: Z-1980-2014 · Initiated June 16, 2014

    Recall

    Recall Number
    Z-1980-2014
    Event Number
    68234
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HKI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 16, 2014
    Posted
    July 2, 2014
    Terminated
    March 3, 2015
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.

    Reason

    Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.

    Action

    Field Correction notifications were sent to all affected users on June 16, 2014 by trackable method.

    Distribution

    Nationwide Distribution.

    Quantity

    185 cameras