BEUDAMED
    FDA Enforcement Class II Terminated

    MyRay RXDC dental unit x-ray unit

    Recall: Z-1217-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1217-2013
    Event ID
    65036
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CEFLA DENTAL GROUP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    August 10, 2012
    Classification Date
    May 23, 2013
    Termination Date
    March 4, 2015
    Address
    VIA BICOCCA 14/C, N/A, IMOLA, BO, N/A, N/A, Italy

    Description

    MyRay RXDC dental unit x-ray unit

    Reason

    The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma

    Code Info

    Model - MyRay RX DC

    Distribution

    FOREIGN: CANADA; DOMESTIC: GA, TX, IL, CA, FL, NY, MA, AL, NJ, SC, WA, LA, MD, WY, CT, NM, WI, CO, NC, VA, PA and MI.

    Quantity

    173 shipped to US