BEUDAMED
    FDA Recall Terminated

    Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System

    Recall: Z-2156-2012 · Initiated July 11, 2012

    Recall

    Recall Number
    Z-2156-2012
    Event Number
    62551
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 11, 2012
    Posted
    August 8, 2012
    Terminated
    March 26, 2013
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System

    Reason

    When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.

    Action

    Philips issued an Urgent Field Safety Notice dated July 2, 2012 to all affected customers. The letter identified the affected product, problem description, actions to be taken by the customer/user in order to prevent risks for patients or users and actions planned by Philips to correct the problem. For question or support concerning this issue contact your local Philips representative.

    Distribution

    Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom

    Quantity

    41 units