BEUDAMED
    FDA Recall Terminated

    MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

    Recall: Z-0032-2012 · Initiated September 1, 2011

    Recall

    Recall Number
    Z-0032-2012
    Event Number
    59853
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 1, 2011
    Posted
    October 7, 2011
    Terminated
    March 13, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

    Reason

    Clinical measurements on true size printouts may be inaccurate

    Action

    Philips Medical notified all affected customers with a "Field Safety Notice" dated August 2011. The letter provides instructions to the customer for how to avoid the problem. Customers are informed that until the software upgrade is recieved from Philip, do not use the true-size printing feature if the system is configured for more than one DICOM printer. Customers will be instructed that they will receive a software upgrade when it is available. For questions on this recall contact Philips representative at (800) 722-9377.

    Distribution

    Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.

    Quantity

    20 units