BEUDAMED
    FDA Recall Terminated

    Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03.

    Recall: Z-0414-2011 · Initiated October 19, 2010

    Recall

    Recall Number
    Z-0414-2011
    Event Number
    57039
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 19, 2010
    Posted
    November 18, 2010
    Terminated
    August 1, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03.

    Reason

    Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.

    Action

    Philips Healthcare issued an Urgent Medical Device Correction letter dated October 15, 2010 to customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. Contact Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377

    Distribution

    Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.

    Quantity

    200 units