BEUDAMED
    FDA Enforcement Class II Terminated

    OPERON D850 Surgical Table Product Usage: Surgical Table

    Recall: Z-2168-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2168-2013
    Event ID
    65960
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Berchtold Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    April 16, 2012
    Classification Date
    September 9, 2013
    Termination Date
    September 10, 2013
    Address
    1950 Hanahan Rd, N/A, N Charleston, SC, 29406-4878, United States

    Description

    OPERON D850 Surgical Table Product Usage: Surgical Table

    Reason

    Table was not lowering.

    Code Info

    3501110-S10023, 3501110-S10024, 3501110-S10025, 3501110-S10205, 3501110-S10208, 3501110-S10064, 3501110-S10036, 3501110-S10043, 3501110-S10045, 3501110-S10050, 3501110-S10061, 3501110-S10062, 3511110-S10139, 3511110-S10143, 3511110-S10144, 3511110-S10162, 3501110-S10192, 3501110-S10018, 3511110-S10038, 3511110-S10041, 3511110-S10047, 3511110-S10072, 3511110-S10137, 3511110-S10138, 3501110-S10153, 3501110-S10166, 3501110-S10093, 3501110-S10104, 3501110-S10090, 3501110-S10147, 3501110-S10262, 3501110-S10281, 3501110-S10105, 3501110-S10172, 3501110-S10195, 3501110-S10109, 3501110-S10134, 3501110-S10099, 3501110-S10101, 3501110-S10151, 3511110-S10086, 3511110-S10092, 3511110-S10085, 3511110-S10091, 3501110-S10065, 3501110-S10037, 3501110-S10056, 3501110-S10259, 3501110-S10083, 3501110-S10170, 3501110-S10212, 3501110-S10067, 3501110-S10073, 3501110-S10116, 3501110-S10117, 3501110-S10119, 3501110-S10157, 3501110-S10167, 3501110-S10204, 3501110-S10207, 3501110S-10110, 3511110-S10234, 3501110-S10078, 3501110-S10034, 3501110-S10035, 3501110-S10097, 3501110-S10112, 3501110-S10088, 3501110-S10096, 3501110-S10098, 3501110-S10102, 3501110-S10111, 3501110-S10019, 3501110-S10021, 3501110-S10022, 3501110-S10223, 3501110-S10267, 3501110-S10049, 3501110-S10044, 3501110-S10052, 3501110-S10149, 3501110-S10121, 3501110-S10129, 3501110-S10254, 3501110-S10257, 3501110-S10263, 3501110-S10100, 3511110-S10176, 3511110-S10221, 3501110-S10026, 3501110-S10051, 3501110-S10211, 3501110-S10251, 3501110-S10046, 3501110-S10053, 3501110-S10054, 3501110-S10055, 3501110-S10063, 3501110-S10080, 3501110-S10028, 3501110-S10027, 3501110-S10027, 3501110-S10152, 3511110-S10161, 3501110-S10079, 3501110-S10095, 3511110-S10039, 3501110-S10103, 3501110-S10209, 3501110-S10213, 3501110-S10076, 3501110-S10114, 350110-S10118, 3501110-S10126, 3501110-S10128, 3501110-S10136, 3501110-S10154, 3501110-S10156, 3501110-S10158, 3501110-S10258, 3501110-S10249, 3501110-S10256, 3501110-S10260, 3501110-S10261, 3501110-S10031, 3501110-S10210, 3501110-S10277, 3501110-S10070, 3501110-10082, 35011100-S10084, 3501110-S10087, 3501110-S10089, 3501110-S10248, 3501110-S10250, 3501110-S10131, 3501110-S10094, 3501110-S10016, 3501110-S10017, 3501110-S10020, 3501110-S10030, 3501110-S10206, 3501110-S10252, 3501110-S10148, 3501110-S10155, 3501110-S10171, 3501110-S10173, 3511110-S10107, 3501110-S10193, 35011110-S10233, 3511110-S10159, 3511110-S10160, 3511110-S10168, 3511110-S10169, 3511110-S10181, 3511110-S10196, 3511110-S10197, 3511110-S10198, 3511110-S10199, 3511110-S10200, 3511110-S10201, 3511110-S10202, 3511110-S10214, 3511110-S10215, 3511110-S10218, 3511110-S10219, 3511110-S10228, 3511110-S10235, 3501110-S10253, 3501110-S10255, 3511110-S10033, 3501110-S10074, 3501110-S10075, 3501110-S10077, 3511110-S10040, 3511110-S10145, 3511110-S10032, 3501110-S10270, 3501110-S10135, 3501110-S10150, 3501110-S10164, 3501110-S10165, 3501110-S10265, 3501110-S10266, 3501110-S10280, 3501110-S10060, 3501110-S10133, 3501110-S10106, 3511110-S10108, 3511110-S10217, 3511110-S10220, 3501110-S10113, 3501110-S10115, 3501110-S10120, 3501110-S10122, 3501110-S10123, 3501110-S10125, 3501110-S10130, 3501110-S10132, 3511110-S10140, 3511110-S10141, 3511110-S10142, 3511110-S10146, 3501110-S10066, 3501110-S10068, 3501110-S10069, 3501110-S10081, 3501110-S10222, 3501110-S10224, 3501110-S10225, 3501110-S10226, 3501110-S10227, 3501110-S10230, 3501110-S10231, 3501110-S10236, 3501110-S10237, 3501110-S10238, 3501110-S10239, 3501110-S10071, 3501110-S10124, 3501110-S10127, 3511110-S10177, 3511110-S10178, 3511110-S10179, 3511110-S10180, 3511110-S10203

    Distribution

    USA Nationwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, HI.IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WI and including Canada.

    Quantity

    263