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U.S. Department of Health and Human Services

Class 2 Device Recall Navigation and Visualization System

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  Class 2 Device Recall Navigation and Visualization System see related information
Date Initiated by Firm July 12, 2004
Date Posted May 11, 2005
Recall Status1 Terminated 3 on August 02, 2011
Recall Number Z-0815-05
Recall Event ID 31057
510(K)Number K040050  K983529  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product InstaTrak 3500 Plus Navigation and Visualization System
Code Information Axcess System Kit P/N: 1005869-001
Recalling Firm/
Manufacturer		 GE OEC Medical Systems,Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact GE Healthcare Field Service
801-517-6717
Manufacturer Reason
for Recall		 Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
FDA Determined
Cause 2		 Other
Action Customers were notified by letter on 07/12/04.
Quantity in Commerce 5 kits
Distribution Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.
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 = LLZ and Original Applicant = GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN
510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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