Recall Z-1985-2012 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomi
| Date | Jul 12, 2012 (initiated Sep 15, 2006) |
| Status | Terminated |
| Reason | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues. |
| Root cause | Software design |
| Action | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notice dated October 11, 2006 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were informed that a GEHC OEC would be contacting their facility to verify the current software version installed at their site. If the issue affects their facility a software upgradewill be provided at no cost. Customers were advised to excercise caut |
| Quantity | 86 units |
| Distribution | Worldwide Distribution - US (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040050 | INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 Ge Medical Systems Navigation and Visualization IN, Mar 24, 2004 |