PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 24, 2014 Initiated: June 17, 2014 #Z-2567-2014

Product Description

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.

Reason for Recall

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

Details

Units Affected
3416
Distribution
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.
Location
Palo Alto, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Varian Medical Systems, Inc.. Units affected: 3416.
Why was this product recalled?
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 24, 2014. Severity: Moderate. Recall number: Z-2567-2014.