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Recall Observatory FDA recall evidence

Device product

OPERON D850 Surgical Table Product Usage: Surgical Table

Z-2168-2013

April 16, 2012

Class II

Product summary

Firm
Berchtold Corp.
Event
Event 65960
Status
Terminated
Classification
Class II
Quantity
263
Official record key
device-enforcement:Z-2168-2013

Official wording

Reason: Table was not lowering.

Code information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Table was not lowering.