Recall Z-0886-2011 ยท GKZ Counter, Differential Cell
Varian Medical Systems Oncology Systems
Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiother
| Date | Jan 8, 2011 (initiated Jun 10, 2010) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Varian sent a Customer Technical Bulletin letter to all affected users on May 27, 2010, and was also posted to Varian's customer support site: http://www.MyVarian.com. The letter identified the product, the problem, and provided instructions on the recall. Customers were instructed to return the proof of notification (via completed "Proof of Notification Form or appropriate Postal system certified receipt of delivery to Varian. For questions regarding this recall call 650-483-3153. |
| Distribution | Worldwide Distribution - USA including CA, TX, IL, GA, NJ, and NV and the countries of Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland, and the UK |
| FDA record | Open on fda.gov |