Class 2 Device Recall BIAD Classic 24 (24" collimator).

• Date Initiated by Firm: August 01, 2006
• Date Posted: November 16, 2006
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0193-2007
• Recall Event ID: 36381
• 510(K)Number: K892875
• Product Classification: gamma camera - Product Code KPS
• Product: BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.
• Code Information: Serial numbers B-102 through B-184
• Recalling Firm/ Manufacturer: Trionix Research Laboratory Inc; 8037 Bavaria Rd; Twinsburg OH 44087-2261
• For Additional Information Contact: Dean F. Brinkley; 330-425-9055
• Manufacturer Reason for Recall: The ball screw on the unit which supports the detector head (which weighs approximately 800 lbs.) could snap resulting in the detector head dropping on the patient.
• FDA Determined Cause: Other
• Action: The recalling firm modified one of the devices in 2002. The remaining device users were telephoned on/about 11/02/2006. To date the recalling firm has not taken any corrective action regarding devices with serial numbers B-102, B-103, B-104 or B-106 thru B-184.
• Quantity in Commerce: 76 devices
• Distribution: Worldwide, including USA, Australia, Egypt, UK, Belgium.
• 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.

• 510(K) Database: 510(K)s with Product Code = KPS