BEUDAMED
    FDA Recall Terminated

    Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    Recall: Z-0223-2015 · Initiated August 6, 2012

    Recall

    Recall Number
    Z-0223-2015
    Event Number
    69508
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    LZS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 6, 2012
    Posted
    November 17, 2014
    Terminated
    November 17, 2014
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    Reason

    Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.

    Action

    Nidek Engineers visited each site to perform correction - fuse holders have been inspected and replaced if necessary. An Engineering Change Order was issued on June 1, 2012, for inspection and/or replacement of affected fuse holders by Nidek Service Engineers. For further questions please call (510) 353-7785.

    Distribution

    US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.

    Quantity

    14 units