Class 2 Device Recall InstaTrak 3500 Plus system

• Date Initiated by Firm: January 26, 2005
• Date Posted: March 30, 2007
• Recall Status: Terminated 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: 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