Company: Varian Medical Systems Inc.
Date of Enforcement Report 1/19/2011
Class ll:
PRODUCT
Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX. The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery. Recall # Z-0886-2011
REASON
The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on May 27, 2010, and web site posting. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2399
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland, and the UK
