BEUDAMED
    FDA Recall Terminated

    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

    Recall: Z-0767-2013 · Initiated January 16, 2013

    Recall

    Recall Number
    Z-0767-2013
    Event Number
    64127
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    January 16, 2013
    Posted
    February 1, 2013
    Terminated
    January 23, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

    Reason

    The 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

    Phillips issued an Urgent Field Safety Notice to all customers on January 14, 2013, to notify users that the Phillips EasyDiagnost Eleva systems, release 3.0 has a mirror icon that could be misinterpereted and could potentially lead to misdiagnosis. Philips will upgrade the system to version 3.1 which involves software and hardware upgrades of the system. This software provides a replacement icon that reduces the risk of the potential misinterpretation of the original mirror icon. Additionally, Philips will provide updated Instructions for Use (IFU) for the Eleva workspot and the EasyDiagnost 3.1 system and an addendum to the EasyDiagnost system IFU. Users will be contacted by Phillips to schedule the installation. For questions contact your local Philips representative: 1-800-722-9377.

    Distribution

    US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.

    Quantity

    14 units