Varian Medical Systems
FDA Regulatory Profile
Varian Medical Systems appears in FDA public data with 23 recalls, 206 510(k) clearances, 23 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1899-2020, Class II) was initiated on August 12, 2019. Its most recent 510(k) clearance was granted on August 3, 2026.
Summary
- Total Recalls
- 23
- 510(k) Clearances
- 206
- Inspections
- 23
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1899-2020 | Class II | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definitio | August 12, 2019 |
| Z-0771-2019 | Class II | Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only | December 26, 2018 |
| Z-0004-2019 | Class II | TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version | August 20, 2018 |
| Z-0005-2019 | Class II | VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems | August 20, 2018 |
| Z-0990-2017 | Class II | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based | December 2, 2016 |
| Z-0077-2017 | Class II | Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). | September 13, 2016 |
| Z-2150-2016 | Class II | Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiolog | June 23, 2016 |
| Z-2149-2016 | Class II | Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE | June 23, 2016 |
| Z-0805-2016 | Class II | Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product U | January 11, 2016 |
| Z-0170-2016 | Class II | ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model | September 28, 2015 |
| Z-1849-2015 | Class II | The VariSource iX series afterloader systems are computer controlled remote electro/mechanical syste | May 18, 2015 |
| Z-1829-2015 | Class II | Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. | May 18, 2015 |
| Z-2654-2014 | Class II | 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accu | August 18, 2014 |
| Z-2567-2014 | Class II | C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac | June 17, 2014 |
| Z-0526-2015 | Class II | Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verificati | April 30, 2014 |
| Z-1502-2014 | Class II | On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. | March 20, 2014 |
| Z-0552-2014 | Class II | Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiati | November 18, 2013 |
| Z-0439-2014 | Class II | C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single | October 24, 2013 |
| Z-0065-2014 | Class II | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Bre | August 9, 2013 |
| Z-1324-2013 | Class II | Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Produ | April 11, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | August 3, 2026 |
| K261306 | AI Contouring (VA10A) | July 10, 2026 |
| K260750 | Virtual Cone (1.0) | July 8, 2026 |
| K253026 | Respiratory Gating for Scanners (2.1) | June 4, 2026 |
| K252717 | MAASTRO Rectal Applicator Set | May 20, 2026 |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | April 23, 2026 |
| K252304 | syngo.via RT Image Suite VC10 | March 18, 2026 |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | January 21, 2026 |
| K252919 | IDENTIFY (5.0) | December 16, 2025 |
| K252884 | Guided Aarhus Applicator Set | November 19, 2025 |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | October 7, 2025 |
| K250099 | Mobius3D (4.1) | May 16, 2025 |
| K250299 | CT/ MR Tandem and Ovoid Set | May 9, 2025 |
| K250289 | Intracavitary/Interstitial System | April 25, 2025 |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | March 3, 2025 |
| K242957 | Identify (4.0) | February 7, 2025 |
| K242608 | Embozene Color-Advanced Microspheres | January 17, 2025 |
| K241764 | Mould Probe MR Safe | January 10, 2025 |
| K242463 | ARIA Radiation Therapy Management System (18.1) | December 13, 2024 |
| K242378 | Eclipse Treatment Planning System (18.1) | December 11, 2024 |