BEUDAMED
    FDA Recall Terminated

    MX8000 Dual v.EXP CT scanner using Version 2.5 software.

    Recall: Z-1414-05 · Initiated March 11, 2005

    Recall

    Recall Number
    Z-1414-05
    Event Number
    32334
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2005
    Posted
    August 30, 2005
    Terminated
    March 2, 2012
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    MX8000 Dual v.EXP CT scanner using Version 2.5 software.

    Reason

    When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.

    Action

    The firm sent recall/field correction letters dated 3/11/05.

    Distribution

    The devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, England, Finland, France, Greece, Germany, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Libya, Mexico, Morocco, Netherlands, New South Wales, New Zealand, Norway, Panama, Phillipines, Portugal, Poland, Romania, Russia, South Africa, Singapore, Slovenia, Spain, Sri Lanka, Switzerland, Sweden, Taiwan, Thailand, Turkey and Venezuela.