BEUDAMED
    FDA Recall Terminated

    Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.

    Recall: Z-0224-2015 · Initiated October 24, 2012

    Recall

    Recall Number
    Z-0224-2015
    Event Number
    69537
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 24, 2012
    Posted
    November 17, 2014
    Terminated
    November 17, 2014
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.

    Reason

    When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.

    Action

    Nidek Field Service engineers visited each affected location to upgrade software.

    Distribution

    US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.

    Quantity

    21affected devices