BEUDAMED
    FDA Recall Terminated

    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

    Recall: Z-2449-2015 · Initiated August 7, 2015

    Recall

    Recall Number
    Z-2449-2015
    Event Number
    71848
    Firm
    Carestream Health Inc
    FEI Number
    1315356
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 7, 2015
    Posted
    August 22, 2015
    Terminated
    July 6, 2016
    Address
    150 Verona St, Rochester, NY, 14608-1733

    Description

    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

    Reason

    Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

    Action

    Carestream sent an Urgent Medical Device Correction letters dated July 29, 2015 and Customer Notification Acknowledgement Forms to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Carestream will update the software on your device to correct this issue. For questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number.

    Distribution

    Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.

    Quantity

    Domestic: 76 units, Foreign: 160 units