BEUDAMED
    FDA Recall Terminated

    GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System.

    Recall: Z-0802-2007 · Initiated December 21, 2006

    Recall

    Recall Number
    Z-0802-2007
    Event Number
    37007
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 21, 2006
    Posted
    May 15, 2007
    Terminated
    July 3, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System.

    Reason

    Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

    Action

    A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.

    Distribution

    Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, Guam and Puerto Rico. Foreign countries include ; Albania, Algeria, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Canada, Chile, China, Columbia, Czechoslovakia, Denmark, Finland, France, Germany, Great Britain, Greece, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, and Vietnam

    Quantity

    1,172