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U.S. Department of Health and Human Services

Class 2 Device Recall OPERON D850 Surgical Table

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 Class 2 Device Recall OPERON D850 Surgical Tablesee related information
Date Initiated by FirmApril 16, 2012
Date PostedSeptember 09, 2013
Recall Status1 Terminated 3 on September 10, 2013
Recall NumberZ-2168-2013
Recall Event ID 65960
Product Classification Table, operating-room, electrical - Product Code GDC
ProductOPERON D850 Surgical Table Product Usage: Surgical Table
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
FEI Number 1220685
Recalling Firm/
Manufacturer		 Berchtold Corp.
1950 Hanahan Rd
N Charleston SC 29406-4878
For Additional Information ContactChris Mannarino
843-569-6100 Ext. 322
Manufacturer Reason
for Recall		Table was not lowering.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBerchtold sent a Customer Notification letter dated April 16, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that BERCHTOLD will upgrade the OPERON Surgical tables with a new firmware version that will eliminate the potential for experiencing problems. For questions call 843-569-6100 ext. 322.
Quantity in Commerce263
DistributionUSA 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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