BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0767-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0767-2013
    Event ID
    64127
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    January 16, 2013
    Classification Date
    February 1, 2013
    Termination Date
    January 23, 2017
    Address
    3000 Minuteman Road, N/A, Andover, MA, 01810, United States

    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.

    Code Info

    Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409

    Distribution

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

    Quantity

    14 units