BEUDAMED
    FDA Enforcement Class II 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 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1404-2013
    Event ID
    65082
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canon Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    December 5, 2012
    Classification Date
    May 25, 2013
    Termination Date
    September 20, 2013
    Address
    30-2, Shimomaruko 3-chome,, Ohta-ku, Tokyo, N/A, N/A, Japan

    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.

    Code Info

    Catalog Number 6937B002AA. All serial numbers from the first unit onward.

    Distribution

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

    Quantity

    384 units