BEUDAMED
    FDA Recall Terminated

    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

    Recall: Z-1821-2012 · Initiated May 11, 2012

    Recall

    Recall Number
    Z-1821-2012
    Event Number
    61877
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 11, 2012
    Posted
    June 18, 2012
    Terminated
    October 6, 2016
    Address
    3000 Minuteman Road, Andover, MA, 01810

    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

    Action

    Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.

    Distribution

    6 US customers

    Quantity

    6