Z-2168-2013 Class II Terminated

Recalled by Berchtold Corp. — N Charleston, SC

FDA device recall Z-2168-2013 was initiated by Berchtold Corp. on April 16, 2012 and is designated Class II. Reason for recall: Table was not lowering. The recall status is terminated (terminated September 10, 2013). Affected quantity: 263.

Recall Details

Product Type
Devices
Report Date
September 18, 2013
Initiation Date
April 16, 2012
Termination Date
September 10, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
263

Product Description

OPERON D850 Surgical Table Product Usage: Surgical Table

Reason for Recall

Table was not lowering.

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.

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