Recall Z-2567-2014 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc.
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 a
| Date | Sep 13, 2014 (initiated Jun 17, 2014) |
| Status | Terminated |
| Reason | Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Urgent Medical Device correction letters were sent on June 16, 2017 to all affected users by certified mail. |
| Quantity | 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, Fran |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.