Z-0704-2007

InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in...

Name: Z-0704-2007 InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in...
Creator: GE OEC Medical Systems,Inc
Published: 2005-01-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-01-26 / Terminated / root cause: software

FDA source

GE OEC Medical Systems,Inc began a recall of InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body) on 2005-01-26. The reason FDA records is "Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0704-2007
Status: Terminated
Initiated: 2005-01-26
Posted: 2007-03-30
Terminated: 2011-07-08
Recalling firm: GE Healthcare
Product: InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
Root cause tag: software
FDA root 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
Product codes and lots: InstaTrak 3500 Plus systems with version 5.1 software. The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.

Product code LLZ

K983529Class IIInstatrak 3000Visualization Technology, Inc. / cleared 1998-12-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)