BEUDAMED
    FDA Recall Terminated

    STERIS 4085, 5085 & 5085SRT Surgical Tables

    Recall: Z-1941-2010 · Initiated May 14, 2010

    Recall

    Recall Number
    Z-1941-2010
    Event Number
    55850
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 14, 2010
    Posted
    June 30, 2010
    Terminated
    February 24, 2012
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    STERIS 4085, 5085 & 5085SRT Surgical Tables

    Reason

    STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table

    Action

    On May 14, 2010 the firm sent FCL letters to their customers notifying them of the problem. They informed their customers that a service representative will contact them to arrange correction of the unit.

    Distribution

    Worldwide distribution: USA, Australia, India, Korea & New Zealand

    Quantity

    79 units