GE OEC Medical Systems, Inc InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
InstaTrak 3500 Plus systems with version 5.1 software. The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
GE OEC Medical Systems, Inc is recalling InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical stru due to Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
Recommended Action
Per FDA guidance
Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, CA, CT, IL, IA, ME, MD, MS, MO, MT, NJ, NY, NC, OH, PA, RI, SD, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026