BEUDAMED
    FDA Recall Terminated

    HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).

    Recall: Z-0178-05 · Initiated September 10, 2004

    Recall

    Recall Number
    Z-0178-05
    Event Number
    30160
    Firm
    Philips Ultrasound, Inc.
    FEI Number
    3019216
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 10, 2004
    Posted
    November 5, 2004
    Terminated
    February 9, 2006
    Address
    22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, WA, 98041-3003

    Description

    HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).

    Reason

    Potential for device to cause burning of the skin.

    Action

    On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output.

    Distribution

    Units were distributed to medial facilities, hospitals, and veterinarians worldwide. Countries include Africa, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Domican Republic, Ecuador, France, Germany, Greece, Guam, Guatemala, Hungary, India, Israel, Italy, Jordan, Kuwait, Martinique, Mexico, Netherlands, New Zealand, Norway, Phlippines, Portugal, Puerto Rico, Peru, Santa Domingo, Saudia Arabia, Selangor, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Zenica

    Quantity

    333 domestic units, 29 demos, 704 international units