Varian Medical Systems, Inc.
18 recalls on record · Latest: May 13, 2020
FDA Devices Moderate May 13, 2020
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): prod…
FDA Devices Moderate Jan 30, 2019
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse …
FDA Devices Moderate Jan 18, 2017
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: T…
FDA Devices Moderate Oct 19, 2016
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with …
FDA Devices Moderate Jul 20, 2016
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indica…
FDA Devices Moderate Jul 20, 2016
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use t…
FDA Devices Moderate Feb 24, 2016
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Ecl…
FDA Devices Moderate Nov 4, 2015
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation On…
FDA Devices Moderate Jul 1, 2015
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
FDA Devices Moderate Dec 24, 2014
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to iso…
FDA Devices Moderate Sep 24, 2014
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23…
FDA Devices Moderate Jan 1, 2014
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions …
FDA Devices Moderate Dec 11, 2013
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. T…
FDA Devices Moderate Oct 30, 2013
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufa…
FDA Devices Moderate May 22, 2013
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate b…
FDA Devices Moderate Feb 6, 2013
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
FDA Devices Moderate Feb 6, 2013
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachyther…
FDA Devices Moderate Dec 26, 2012