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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 Recall
InstaTrak 3500 Plus system
see related information
Date Posted March 30, 2007
Recall Status1 Open
Recall Number Z-0704-2007
Recall Event ID 31058
Premarket Notification
510(K) Number
K983529 
Product Classification System, Image Processing, 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, Utah 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
DESIGN: Software Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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