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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall BIAD Classic 24 (24" collimator). see related information
Date Initiated by Firm August 01, 2006
Date Posted November 16, 2006
Recall Status1 Terminated 3 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 2
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 and Original Applicant = TRIONIX RESEARCH LABORATORY, INC.
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