BEUDAMED
    FDA Recall 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 · Initiated May 24, 2013

    Recall

    Recall Number
    Z-0222-2015
    Event Number
    69531
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 24, 2013
    Posted
    November 17, 2014
    Terminated
    November 17, 2014
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    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.

    Action

    Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.

    Distribution

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

    Quantity

    5