BEUDAMED
    FDA Recall Terminated

    Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.

    Recall: Z-0522-2009 · Initiated August 12, 2008

    Recall

    Recall Number
    Z-0522-2009
    Event Number
    49065
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 12, 2008
    Posted
    December 31, 2008
    Terminated
    July 14, 2011
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.

    Reason

    The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.

    Action

    On 8/12/08, the firm sent an Urgent - Medical Device Correction letter, dated July 2008, to all affected customers via UPS. The letter describes the reason for the recall, informs them that Philips Ultrasound is correcting the error, states that the software is under development, will be available in September 2008 and will contact the customer to upgrade their system. "In the interim, Philips recommends that you only use the Hadlock or Osaka growth tables to perform your EFW Growth Percentile calculations. You should make the appropriate selections in the Analysis Setup menu on your system."

    Distribution

    Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bosnia, Brazil, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Rep, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Kuwait, Malaysia, Martinique, Mexico, Moldova, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Utd Arab Emirr., Venezuela, Viet Nam, Canada, Afghanistan, Albania, Argentina, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Korea Rep, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Moldova, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, SLOVAKIA, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Kingdom, Uzbekistan, Venezuela, and Virgin Isl (Br).

    Quantity

    4279 units