BEUDAMED
    FDA Recall Terminated

    Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

    Recall: Z-0491-2014 · Initiated August 29, 2013

    Recall

    Recall Number
    Z-0491-2014
    Event Number
    66744
    Firm
    Carestream Health Inc.
    FEI Number
    1315356
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 29, 2013
    Posted
    January 3, 2014
    Terminated
    November 18, 2015
    Address
    150 Verona St, Rochester, NY, 14608-1733

    Description

    Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

    Reason

    It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.

    Action

    Carestream sent a letter to all affected customers informing them of the issue, how to detect the issue and actions to be taken by Carestream to correct the issue. The actions to be taken by Carestreamn to correct the issue will include the installation of a software patch to mitigate the effects of the observed failure and remove the possibility of a re-exposure in this failure mode. The correction will be implemented within the US to all affected devices at identified customer sites. For further questions call Carestream Customer Care at 1-800-328-2910, 8 am through 8 pm Eastern Standard Time.

    Distribution

    Nationwide

    Quantity

    310 systerms domestically