BEUDAMED
    FDA Recall Terminated

    Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography.

    Recall: Z-1178-2012 · Initiated April 1, 2011

    Recall

    Recall Number
    Z-1178-2012
    Event Number
    61311
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 1, 2011
    Posted
    March 27, 2012
    Terminated
    August 23, 2016
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography.

    Reason

    It was discovered in some instances the detector did not reset as quickly as the user prompted a change form one image receptor (auxiliary) to the next, and then back again.

    Action

    An Important Electronic Product Radiation Warning letter, dated February 28, 2012, was sent to customers. The letter identified the affected product, a description of the issue, the hazard involved, along with the actions to be taken and planned. Customers were to use one of the three work-a-rounds provided. The issue will be corrected with Field Change Order 70600064, which consists of a Software Update 4.0.2SP Service Pack installed on the system. If further information or support is needed, customers can contact Dominic Siewko at 978-659-7936.

    Distribution

    Worldwide Distribution - Including USA.

    Quantity

    96