BEUDAMED
    FDA Recall Terminated

    Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034 Product Usage: Radiological image processing system (computed radiography x-ray system)

    Recall: Z-1216-2012 · Initiated February 14, 2012

    Recall

    Recall Number
    Z-1216-2012
    Event Number
    61204
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 14, 2012
    Posted
    March 15, 2012
    Terminated
    September 23, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034 Product Usage: Radiological image processing system (computed radiography x-ray system)

    Reason

    Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system

    Action

    Philips Healthcare sent an Urgent Medical Device Correction letter dated February 8, 2012 to all affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter contains important information for continue safe and proper use of the equipment. Philips will contact customers to schedule the installation of the updated software. For further information or support contact your local Philips representative at the Technical Support Line 866-767-2822.

    Distribution

    Worldwide Distribution - USA Nationwide

    Quantity

    60 units