BEUDAMED
    FDA Recall Terminated

    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.

    Recall: Z-0196-2015 · Initiated October 10, 2014

    Recall

    Recall Number
    Z-0196-2015
    Event Number
    69472
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    GDC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 10, 2014
    Posted
    November 7, 2014
    Terminated
    June 26, 2015
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.

    Reason

    The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.

    Action

    STERIS will mail Consignee Notification Letters to the affected Consignees via FedEx with tracking numbers for delivery confirmation. The Consignee Notification mailing will initiate the week of October 13, 2014.

    Distribution

    US distribution: AL, AZ, AR, CA, CO, CN, DC, FL, GA, HI, ID, IL, IN, IA, KN, KY, LA, ME, MD, MI, MN, MS, MO, NB, NV, NY, NC, ND, OH, OK, OR, PN, RI, SC, SD, TN, TX, VA, WV, WI. Foriegn: Austrialia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Pnama, and Thailand.

    Quantity

    999