Company:GE OEC Medical Systems,Inc
Date of Enforcement Report:4/6/2007
Class:ll

PRODUCT
InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body), Recall # Z-0704-2007

REASON
Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.

CODE
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., Salt Lake City, UT, by firm representative visit beginning in April, 2004. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
91 units

DISTRIBUTION
Nationwide and Internationally