BEUDAMED
    FDA Enforcement Class II 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 · Reported August 6, 2014

    Enforcement

    Recall Number
    Z-2132-2014
    Event ID
    68766
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2014
    Initiation Date
    June 9, 2014
    Classification Date
    July 30, 2014
    Termination Date
    November 24, 2014
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474, United States

    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.

    Code Info

    Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.

    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)