Recall Z-0524-2014 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
| Date | Dec 17, 2013 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products. |
| Root cause | Software Design Change |
| Action | GE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952. |
| Quantity | 654 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960330 | INSTATRAK Visualization Technology, Inc., Apr 8, 1996 |