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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-0812-05
Recall Event ID 31057
510(K)Number K960330  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product ENTrak Navigation and Visualization System

Code Information Axcess System Kit P/N: 1005869-001
Recalling Firm/
GE OEC Medical Systems,Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact GE Healthcare Field Service
Manufacturer Reason
for Recall
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
FDA Determined
Cause 2
Action Customers were notified by letter on 07/12/04.
Quantity in Commerce 2 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 = VISUALIZATION TECHNOLOGY, INC.