BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

    Recall: Z-1821-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1821-2012
    Event ID
    61877
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    May 11, 2012
    Classification Date
    June 18, 2012
    Termination Date
    October 6, 2016
    Address
    3000 Minuteman Road, N/A, Andover, MA, 01810, United States

    Description

    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

    Reason

    If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut

    Code Info

    All systems with Eleva software version 4.x and stitching option.

    Distribution

    6 US customers

    Quantity

    6