BEUDAMED
    FDA Recall Terminated

    STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.

    Recall: Z-0279-2012 · Initiated October 17, 2011

    Recall

    Recall Number
    Z-0279-2012
    Event Number
    60305
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 17, 2011
    Posted
    November 23, 2011
    Terminated
    March 19, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.

    Reason

    Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.

    Action

    On October 17, 2011, Steris sent 'Urgent Voluntary Field Correction Notices' to their customers via Fedex with tracking numbers for delivery confirmation. The letter identifies the affected product and notifies the user/customers of the problem with the surgical tables. The notification letter goes on to inform the customers that a STERIS Service Representative will be contacting them to arrange for the field correction of the affected unit(s). This involves the replacement of the hydraulic column cylinder of each surgical table(s).

    Distribution

    Nationwide distribution.

    Quantity

    167 tables were distributed - 5085=108 and 5085SRT=59