Varian Medical Systems, Inc. Oncology Systems
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1163-2013 | Class II | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 P | March 26, 2013 |
| Z-0867-2013 | Class II | Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclip | January 28, 2013 |
| Z-0531-2013 | Class II | Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Ex | November 5, 2012 |
| Z-0187-2013 | Class II | ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncol | September 24, 2012 |
| Z-2462-2012 | Class II | Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/F | August 17, 2012 |
| Z-2383-2012 | Class II | Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, | August 14, 2012 |
| Z-2153-2012 | Class II | Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/ | July 2, 2012 |
| Z-2041-2012 | Class II | Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product | June 18, 2012 |
| Z-1325-2013 | Class II | Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, | May 31, 2011 |