BEUDAMED
    FDA Recall Terminated

    Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI

    Recall: Z-0826-2008 · Initiated January 4, 2008

    Recall

    Recall Number
    Z-0826-2008
    Event Number
    45532
    Firm
    Xoran Technologies, Inc.
    FEI Number
    3004198450
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 4, 2008
    Posted
    February 7, 2008
    Terminated
    October 22, 2010
    Address
    309 N 1st St, Ann Arbor, MI, 48103-3301

    Description

    Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI

    Reason

    Misbranding; These devices do not bear the manufacturer's name or address.

    Action

    Consignees were notified via letter, Urgent Medical Device Correction, dated 1/4/08 of the need to apply proper labeling to the products, and were sent instructions and labeling to affix to their units.

    Distribution

    Nationwide.

    Quantity

    71