Recall Z-2567-2014— Varian Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2014-06-17, terminated 2018-09-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode..
- Recalling firm
- Varian Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-17
- Terminated
- 2018-09-20
- Firm location
- Palo Alto, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.