BEUDAMED
    FDA Recall Terminated

    i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam

    Recall: Z-1646-2008 · Initiated March 19, 2008

    Recall

    Recall Number
    Z-1646-2008
    Event Number
    47535
    Firm
    Imaging Sciences Intl Inc
    FEI Number
    3021551875
    Product Code
    MUH
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 19, 2008
    Posted
    September 1, 2008
    Terminated
    May 5, 2009
    Address
    1910 N Penn Rd, Hatfield, PA, 19440-1960

    Description

    i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam

    Reason

    Incorrect scatter information in the manual.

    Action

    Firm issued Urgent Medical Device Recall letters dated 3/19/08 to their customers. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. If you have questions or have not received this letter, contact Francine McCoonse at 215-997-5666 ext 1340.

    Distribution

    The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada, Austria, Belgium, Czech Republic, England, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Lavenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Australia, New Zealand, Chile, Israel, South Korea, UAE, India, Argentina, Brazil, China, Columbia, Hong Kong, Jamaica, Korea, Lebanon, Malaysia, Morocco, Russia, Scotland, Taiwan, Thailand, and Singapore.

    Quantity

    1203 units