Recall Z-0691-05 ยท LLZ System, Image Processing, Radiological
OEC Medical Systems, Inc
InstaTrak 3500 Plus Navigation and Visualization System
| Date | Apr 8, 2005 (initiated Dec 13, 2004) |
| Status | Terminated |
| Reason | Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised. |
| Root cause | Other |
| Action | Customers were notified by letter on 12/13/04. |
| Quantity | 57 units |
| Distribution | Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada. |
| 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 |