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.
FDA Recall Z-1217-2012 · Posted 2012-03-16
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-01-30
Date Terminated2013-10-21
Product Quantity201
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.