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Varian Medical Systems, Inc.

49 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowled recall (Z-0990-2017)Varian Medical Systems, Inc.2017-01-10
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1 recall (Z-0077-2017)Varian Medical Systems, Inc.2016-10-13
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's Tru recall (Z-2149-2016)Varian Medical Systems, Inc.2016-07-11
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; R recall (Z-2150-2016)Varian Medical Systems, Inc.2016-07-11
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Pro recall (Z-0805-2016)Varian Medical Systems, Inc.2016-02-12
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. recall (Z-0170-2016)Varian Medical Systems, Inc.2015-10-30
The VariSource iX series afterloader systems are computer controlled remote electro/mechan recall (Z-1849-2015)Varian Medical Systems Inc2015-06-26
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. recall (Z-1829-2015)Varian Medical Systems Inc2015-06-23
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for ver recall (Z-0526-2015)Varian Medical Systems, Inc.2014-12-16
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for recall (Z-2654-2014)Varian Medical Systems, Inc.2014-09-16
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac recall (Z-2567-2014)Varian Medical Systems, Inc.2014-09-13
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow mot recall (Z-1502-2014)Varian Medical Systems, Inc.2014-04-24
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA recall (Z-0552-2014)Varian Medical Systems, Inc.2013-12-20
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQU recall (Z-0439-2014)Varian Medical Systems, Inc.2013-12-03
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR US recall (Z-0065-2014)Varian Medical Systems, Inc.2013-10-24
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR recall (Z-1324-2013)Varian Medical Systems, Inc.2013-05-15
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring recall (Z-0759-2013)Varian Medical Systems, Inc.2013-01-31
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tan recall (Z-0760-2013)Varian Medical Systems, Inc.2013-01-31
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube fo recall (Z-0607-2013)Varian Medical Systems, Inc.2012-12-20
VariSeed 7.1, software application, part number H62, manufactured by Varian Medical System recall (Z-1385-2012)Varian Medical Systems, Inc.2012-04-10
Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with recall (Z-1199-2012)Varian Medical Systems, Inc.2012-03-12
Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, recall (Z-1200-2012)Varian Medical Systems, Inc.2012-03-12
VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The recall (Z-0325-2012)Varian Medical Systems, Inc.2011-12-01
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled ra recall (Z-0326-2012)Varian Medical Systems, Inc.2011-12-01
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 mm. Remote controlled ra recall (Z-0327-2012)Varian Medical Systems, Inc.2011-12-01
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled ra recall (Z-0328-2012)Varian Medical Systems, Inc.2011-12-01
GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian recall (Z-0295-2012)Varian Medical Systems, Inc.2011-11-30
Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segme recall (Z-0282-2012)Varian Medical Systems, Inc.2011-11-23
Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a componen recall (Z-3204-2011)Varian Medical Systems, Inc.2011-09-14
BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Pal recall (Z-3103-2011)Varian Medical Systems, Inc.2011-08-31
Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed recall (Z-0821-2011)Varian Medical Systems Inc.2010-12-28
VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titan recall (Z-2081-2008)Varian Medical Systems, Inc.2008-09-16
Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Ver recall (Z-0720-2008)Varian Medical Systems Inc2008-02-15
Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy syste recall (Z-0544-2008)Varian Medical Systems Inc2008-02-14
Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy syste recall (Z-0545-2008)Varian Medical Systems Inc2008-02-14
Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1. recall (Z-0554-2008)Varian Medical Systems Inc2008-01-29
Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Informati recall (Z-0213-2008)Varian Medical Systems Inc2007-11-08
Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomo recall (Z-1195-2007)Varian Medical Systems Inc2007-08-29
Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C recall (Z-1074-2007)Varian Medical Systems Inc2007-07-12
LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, recall (Z-0978-2007)Varian Medical Systems Inc2007-06-28
4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy recall (Z-0304-2007)Varian Medical Systems Inc2006-12-19
Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy recall (Z-0194-2007)Varian Medical Systems Inc2006-11-16
Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included recall (Z-1206-06)Varian Medical Systems Inc2006-07-06
Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and inclu recall (Z-0393-06)Varian Medical Systems Inc2006-01-18
Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); recall (Z-1530-05)Varian Medical Systems Inc2005-09-09
Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capabili recall (Z-0777-05)Varian Medical Systems Inc2005-04-27
medical device and software systems recall (Z-1314-04)Varian Medical Systems Inc2004-08-07
Linear accelerator workstation software suite recall (Z-1084-04)Varian Medical Systems Inc2004-07-20
VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2. recall (Z-0633-03)Varian Medical Systems Inc2003-03-12

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Every clearance here is in the API, with alerts when new ones post.