BEUDAMED
    FDA Recall Terminated

    AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03

    Recall: Z-0421-03 · Initiated December 18, 2002

    Recall

    Recall Number
    Z-0421-03
    Event Number
    25055
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2002
    Posted
    January 11, 2003
    Terminated
    April 7, 2004
    Address
    1921 Hurd Drive PO Box 2020, Irving, TX, 75038

    Description

    AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03

    Reason

    Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.

    Action

    Abbott Laboratories sent a December 18, 2002 letter to all consignees informing consignees of their plans to install a locking mechanism on all AxSYM Systems. The installations will be performed by Abbott Representatives. A customer reply form was included in the device correction letter.

    Distribution

    Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Canada, Germany, Ireland, England, Belgium, France, Austria, Italy, Spain, Russia, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Korea, Australia, New Zeland, Honduras, Costa Rica, Trinidad, Bahamas, Northern Antilles, Bermuda, Panama, West Indies, Paraguay, Norway, Kingstow, VC

    Quantity

    18,832 units