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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 January 21, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on August 13, 2012
Recall Number Z-0398-2012
Recall Event ID 60440
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product OR table TITAN UT, Surgical Table.

Surgical bed with Orthopedic Accessories.
Code Information Material number 1465166, All Serial numbers.
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
415 Jessen Ln
Charleston SC 29492
For Additional Information Contact Lindsey Ronneberg
843-822-6939
Manufacturer Reason
for Recall		 Product is being recalled due to unintended movement on the Titan Tables.
FDA Determined
Cause 2		 Device Design
Action Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.
Quantity in Commerce see line 1.
Distribution Worldwide Distribution.
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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