BEUDAMED
    FDA Recall Terminated

    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.

    Recall: Z-1127-2014 · Initiated January 24, 2014

    Recall

    Recall Number
    Z-1127-2014
    Event Number
    67349
    Firm
    Carestream Health Inc.
    FEI Number
    1315356
    Product Code
    EHD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 24, 2014
    Posted
    March 4, 2014
    Terminated
    June 18, 2015
    Address
    150 Verona St, Rochester, NY, 14608-1733

    Description

    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.

    Reason

    Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

    Action

    Urgent Medical Device Recall Letters (dated 1/24/2014) were sent to the consignees on 1/24/2014 via Certified Mail, Return Receipt Requested.

    Distribution

    Worldwide distribution. USA (nationwide) and the country of Canada.

    Quantity

    Domestic: 347 units (total for both)