BEUDAMED
    FDA Recall 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 · Initiated June 3, 2013

    Recall

    Recall Number
    Z-1877-2013
    Event Number
    65369
    Firm
    Carestream Health Inc.
    FEI Number
    1315356
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 3, 2013
    Posted
    August 12, 2013
    Terminated
    January 29, 2014
    Address
    150 Verona St, Rochester, NY, 14608-1733

    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.

    Action

    Carestream will make the correction which includes the installation of a SW patch to the affected customer sites, and to any other affected customer sites utilizing the DRX Evolution with V5. 5 SW outside of the US. --- Once receiving FDA approval on the corrective action plan, the correction will be implemented to all affected devices at identified customer sites: 1. A notification letter was sent to all customers identifying the issue and highlighting the approved procedures of the Corrective Action Plan. The letters were sent on 8/16/13 via Certified Mail, Return Receipt Requested. 2. Carestream Health will contact the customer to schedule a service visit to install software updates to correct this issue. The installation time will be approximately one hour. 3. As stated in the customer notification letter, this software update will be provided to the customer at no expense. 4. All software updates are estimated to be completed within 1-3 months. 5. Carestream Health will provide monthly progress reports on the effectiveness of the plan, including the number of units corrected. Further questions please call (800) 328-2910.

    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)