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U.S. Department of Health and Human Services

Class 2 Device Recall InstaTrak 3500 Plus system

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  Class 2 Device Recall InstaTrak 3500 Plus system see related information
Date Initiated by Firm January 26, 2005
Date Posted March 30, 2007
Recall Status1 Terminated 3 on July 08, 2011
Recall Number Z-0704-2007
Recall Event ID 31058
510(K)Number K983529  
Product Classification Image Processing system-Radiological - Product Code LLZ
Product InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
Code Information InstaTrak 3500 Plus systems with version 5.1 software.   The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems,Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact Karen Tolson
847-501-1884
Manufacturer Reason
for Recall		 Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
FDA Determined
Cause 2		 Other
Action Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2
Quantity in Commerce 91 systems (version 5.1 software)
Distribution Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada
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.
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