Recall Z-1217-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software.
| Date | Mar 16, 2012 (initiated Jan 30, 2012) |
| Status | Terminated |
| Reason | An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to "Discard" that slice, an incorrect calculation of the isocenter location may result. |
| Root cause | Device Design |
| Action | "Urgent Medical Device Correction/Urgent Field Safety Notification" letters were sent on January 30, 2012 by certified mail to consignees in the US and by Federal Express for Canada. International sites will be notified by Varian International Customer Support Managers, who will translate letters if necessary. The notice provided a description of the issue, the actions that can be taken to avoid or mitigate the issue, and the steps Varian is taking to address the issue. Customer service number for US and Canada is: (888) 827-4265. |
| Quantity | 201 |
| Distribution | Worldwide Distribution - Nationwide (USA) and the countries of Canada, China, Germany, Ireland, Spain, Singapore, Georgia, Hong Kong, India, Macau, Malaysia, Russia, Sri Lanka, Taiwan, Japan, Chile, Columbia, Venezuela and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962792 | LINAC SCALPEL TREATMENT PLANNING SYSTEM Surgical Navigation Technologies, Inc., Nov 12, 1996 |