BEUDAMED
    FDA Recall Terminated

    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

    Recall: Z-2132-2014 · Initiated June 9, 2014

    Recall

    Recall Number
    Z-2132-2014
    Event Number
    68766
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 9, 2014
    Posted
    July 30, 2014
    Terminated
    November 24, 2014
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

    Reason

    Laser aperture label was not affixed to device prior to shipment in the US.

    Action

    Nidek sent a Recall/Field Correction letter dated June 9, 2014, to all affected customers. The letter advised customers of the issues and informed customers that Nidek Representatives will visit each location to affix the proper labeling to the device. Customers with questions were instructed to contact Nidek Customer Service at 1-800-223-9044 M-F 8 am to 5 pm PST. For questions regarding this recall call 510-353-7785.

    Distribution

    Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.

    Quantity

    29 units (26 already re-labeled)