BEUDAMED
    FDA Enforcement Class II Terminated

    Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    Recall: Z-1877-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1877-2013
    Event ID
    65369
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    June 3, 2013
    Classification Date
    August 12, 2013
    Termination Date
    January 29, 2014
    Address
    150 Verona St, Rochester, NY, 14608-1733, United States

    Description

    Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    Reason

    Due to potential for an x-ray exposure technique change.

    Code Info

    Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software

    Distribution

    Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

    Quantity

    US: 49 units; Foreign: 183 units (revised)