BEUDAMED
    FDA Enforcement Class II 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 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0196-2015
    Event ID
    69472
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2014
    Initiation Date
    October 10, 2014
    Classification Date
    November 7, 2014
    Termination Date
    June 26, 2015
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    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.

    Code Info

    5085 and 5085SRT

    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