Class 3 Device Recall ORBIT PT

• Date Initiated by Firm: July 24, 2013
• Date Posted: November 05, 2013
• Recall Status: Terminated on June 03, 2014
• Recall Number: Z-0155-2014
• Recall Event ID: 66587
• Product Classification: Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
• Product: ORBIT PT.; ; The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
• Code Information: Item No. 1275499, Serial No. 100711351
• Recalling Firm/ Manufacturer: Trumpf Medical Systems; 1046 Legrand Blvd; Charleston SC 29492-7672
• For Additional Information Contact: Lindsey Ronnenberg; 888-474-9359
• Manufacturer Reason for Recall: An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.
• FDA Determined Cause: Component design/selection
• Action: The user facility was contacted via phone in early August. They were contacted 9/17/2013 to schedule the replacement of the power pack because the new power pack became available.
• Quantity in Commerce: One
• Distribution: US Distribution: NJ only.
• 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.