BEUDAMED
    FDA Enforcement Class II Terminated

    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.

    Recall: Z-0222-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0222-2015
    Event ID
    69531
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 26, 2014
    Initiation Date
    May 24, 2013
    Classification Date
    November 17, 2014
    Termination Date
    November 17, 2014
    Address
    47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States

    Description

    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.

    Reason

    Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.

    Code Info

    MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609

    Distribution

    US Distribution in the states of: CA, NE, and NY.

    Quantity

    5