Recall Z-0181-2008 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862
| Date | Nov 10, 2007 (initiated Mar 23, 2007) |
| Status | Terminated |
| Reason | Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure. |
| Root cause | Component change control |
| Action | Consignees were sent an Urgent Recall Notice letter, via mail dated 10/11/07, advising users to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus System. Once a solution is identified, a representative will contact consignees to arrange for installation of the solution at no charge. |
| Quantity | 61 units |
| Distribution | Class II Recall - Worldwide Distribution - USA including states of AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, NC, NY, OK, PA, SC, TX, UT, VA, and WI, and countries of Canada, China, Germany, Hong Kong, Italy, Japan, Mexico, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050400 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML Becton, Dickinson & CO, Mar 22, 2005 |