C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 23
FDA device recall Z-2567-2014 · posted 2014-09-13 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
- Action taken
- Urgent Medical Device correction letters were sent on June 16, 2017 to all affected users by certified mail.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- IYE
- Quantity 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,
- Date initiated
- 2014-06-17
- Date posted
- 2014-09-13
- Date terminated
- 2018-09-20
- Location
- Palo Alto, CA
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