Varian Medical Systems, Inc. recalls C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 23

Recalled September 24, 2014 · FDA recall Z-2567-2014 · Varian Medical Systems

Hazard

Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode. · FDA Class II

Units

3416

Sold at

Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Byelarus, Belgium, Bosniak, Brazil;, Bulgaria, Burma, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Luxembourg, Macau, Macedonia, Malaysia, Mauritania, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia,, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.

Description

Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.

Product

C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Manufacturer(s)

Varian Medical Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →