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U.S. Department of Health and Human Services

Class 2 Device Recall TITAN

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  Class 2 Device Recall TITAN see related information
Date Initiated by Firm October 09, 2014
Date Posted October 27, 2014
Recall Status1 Terminated 3 on March 23, 2016
Recall Number Z-0141-2015
Recall Event ID 69426
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
Product TITAN Operating Room Table

Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
Code Information TITAN Operating Tables: 1465166, 1228073, 1397903, 4544260.
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
1046 Legrand Blvd
Charleston SC 29492-7672
For Additional Information Contact Lindsey Ronnenberg
843-534-0606
Manufacturer Reason
for Recall		 Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.
FDA Determined
Cause 2		 Device Design
Action TRUMPF sent an Urgent Medical Device Correction letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Complete and return the attached Confirmation of Receipt form with serial numbers of the TITAN table(s) and the serial number(s) for any remote controls you have. We will then arrange to send replacement remotes, which have been redesigned to eliminate this mode of failure. You will then be required to dispose of your recalled remotes. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359.
Quantity in Commerce 184 units
Distribution Worldwide Disttribution: US (nationwide) including the states of AL, AZ, CT, FL, GA, IA, IL, IN, KS, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WA and WY: and Internationally to Canada.
Total Product Life Cycle TPLC 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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