Varian Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
200
Inspections
23
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1899-2020Class IIVarian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High DefinitioAugust 12, 2019
Z-0771-2019Class IIEclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only December 26, 2018
Z-0004-2019Class IITrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System versionAugust 20, 2018
Z-0005-2019Class IIVitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systemsAugust 20, 2018
Z-0990-2017Class IIEclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based December 2, 2016
Z-0077-2017Class IIVarian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). September 13, 2016
Z-2150-2016Class IIOptical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; RadiologJune 23, 2016
Z-2149-2016Class IIOptical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGEJune 23, 2016
Z-0805-2016Class IIEclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product UJanuary 11, 2016
Z-0170-2016Class IIARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model September 28, 2015
Z-1849-2015Class IIThe VariSource iX series afterloader systems are computer controlled remote electro/mechanical systeMay 18, 2015
Z-1829-2015Class IISurface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.May 18, 2015
Z-2654-2014Class II4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accuAugust 18, 2014
Z-2567-2014Class IIC-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, ClinacJune 17, 2014
Z-0526-2015Class IIVarian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verificatiApril 30, 2014
Z-1502-2014Class IIOn-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. March 20, 2014
Z-0552-2014Class IIPlan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA RadiatiNovember 18, 2013
Z-0439-2014Class IIC-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single October 24, 2013
Z-0065-2014Class IIVARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** BreAugust 9, 2013
Z-1324-2013Class IISegmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) ProduApril 11, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K252304syngo.via RT Image Suite VC10March 18, 2026
K252977Halcyon, Ethos Radiotherapy System (5.0)January 21, 2026
K252919IDENTIFY (5.0)December 16, 2025
K252884Guided Aarhus Applicator SetNovember 19, 2025
K252948TrueBeam, TrueBeam STX, Edge and VitalBeamOctober 7, 2025
K250099Mobius3D (4.1)May 16, 2025
K250299CT/ MR Tandem and Ovoid SetMay 9, 2025
K250289Intracavitary/Interstitial SystemApril 25, 2025
K243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)March 3, 2025
K242957Identify (4.0)February 7, 2025
K242608Embozene Color-Advanced MicrospheresJanuary 17, 2025
K241764Mould Probe MR SafeJanuary 10, 2025
K242463ARIA Radiation Therapy Management System (18.1)December 13, 2024
K242378Eclipse Treatment Planning System (18.1)December 11, 2024
K242961Intraluminal Applicator SetNovember 26, 2024
K242874Gating Reflector BlockNovember 21, 2024
K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveNovember 7, 2024
K241965Catheter Surface Flap Applicator Set (GM11011830)October 29, 2024
K241876Vitesse (5.0)October 23, 2024
K242794ONCOZENE MicrospheresOctober 16, 2024