BEUDAMED
    FDA Enforcement Class III Terminated

    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

    Recall: Z-2142-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2142-2014
    Event ID
    68647
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2014
    Initiation Date
    July 2, 2014
    Classification Date
    August 1, 2014
    Termination Date
    May 25, 2016
    Address
    150 Verona St, N/A, Rochester, NY, 14608-1733, United States

    Description

    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

    Reason

    The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.

    Code Info

    Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1

    Distribution

    Worldwide Distribution.

    Quantity

    1633 boxes