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
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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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