Recall Z-0704-2007 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems,Inc
InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
| Date | Mar 30, 2007 (initiated Jan 26, 2005) |
| Status | Terminated |
| Reason | Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software. |
| Root cause | Other |
| Action | Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983529 | INSTATRAK 3000 Visualization Technology, Inc., Dec 31, 1998 |