Device Recall InstaTrak 3500 Plus system

InstaTrak 3500 Plus systems with version 5.1 software.   The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.

Radiology Devices

2

No

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

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