BEUDAMED
    FDA Recall Terminated

    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

    Recall: Z-1404-2013 · Initiated December 5, 2012

    Recall

    Recall Number
    Z-1404-2013
    Event Number
    65082
    Firm
    Canon Inc. 30-2, Shimomaruko 3-chome, Ohta-ku Tokyo Japan
    FEI Number
    1000181430
    Product Code
    HKO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 5, 2012
    Posted
    May 25, 2013
    Terminated
    September 20, 2013

    Description

    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

    Reason

    Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.

    Action

    Canon initiated recall by sending letters on November 22, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken and contact information.

    Distribution

    Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.

    Quantity

    384 units