BEUDAMED
    FDA Recall Terminated

    iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage

    Recall: Z-0948-2009 · Initiated December 29, 2008

    Recall

    Recall Number
    Z-0948-2009
    Event Number
    50751
    Firm
    Philips Healthcare Informatics, Inc.
    FEI Number
    3002971142
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 29, 2008
    Posted
    January 30, 2009
    Terminated
    November 29, 2010
    Address
    4100 E 3rd Ave, Ste 101, Foster City, CA, 94404-4819

    Description

    iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage

    Reason

    Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.

    Action

    Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in "Q1 2009". For additional information, contact Philips at 650-293-2624.

    Distribution

    International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.

    Quantity

    40 units