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Varian Medical Systems, Inc

United States·US-MF-000001784

Last updated September 17, 2026

Information

Country: United States
Address: 9825, Spectrum Drive, Austin, United States
Website: siemens-healthineers.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Zachary Bullock
EUDAMED SRN: US-MF-000001784
FDA FEI Number: 2916710
DUNS Number: —

Catalogue (653)

Page 1 of 14

Device	Model / Reference	Registries	Class	Status
Breast bridge assembly	AL07375000	EUDAMED	Class IIa	Active
Medium stabilization rail, length 150 mm	AL07386000	EUDAMED	Class IIa	Active
Medium guide template, size 150 mm	AL07383000	EUDAMED	Class IIa	Active
Small fixed template, size 100 mm	AL07376000	EUDAMED	Class IIa	Active
Small stabilization rail, length 100 mm	AL07385000	EUDAMED	Class IIa	Active
Beacon Care Package - Soft Tissue (17G)	ASM0607-002	FDA UDI	Class II	Active
Unique Single Energy Medical Charged Particle Radiation Therapy System	9.1	FDA UDI	Class II	Active
Titanium Flexible Geometry FSD Applicator Set	GM11013400	FDA UDI	Class II	Active
Varian Acuity with Conebeam Computed Tomography	2.1	FDA UDI	Class II	Active
Ovoid mini Ø16 mm Left	GM94066760	FDA UDI	Class II	Active
Leak Stop Channel Marker - Channel 3 - 25 pack	Channel 3	FDA UDI	Class II	Active
Cleaning caps, black (pack of 20) (interstitial tube connector)	GM11003360	FDA UDI	Class II	Unknown
Varian Collimator Accessories Upper port film graticule for MLC	10004249718	FDA UDI	Class II	Active
Leak Stop Channel Marker - Channel 17 - 25 pack	Channel 17	FDA UDI	Class II	Active
Cleaning caps, black (pack of 20) (interstitial tube connector)	GM11003360	FDA UDI	Class II	Active
Varian Collimator Accessories Upper Compensator Tray Assy	88839003	FDA UDI	Class II	Active
Varian RPM Gating Marker Block (2 Dot)	1107081-01	FDA UDI	Class II	Active
RPM Respiratory Gating System	1.8	FDA UDI	Class II	Active
80 Leaf Assy, MLC Head	8.5	FDA UDI	Class II	Active
OmniBone Bone Biopsy Kit with 11 Gauge 158mm length	OMB 11/15	FDA UDI	Class II	Active
Millennium 80-leaf Multileaf Collimator	8.1	FDA UDI	Class II	Active
Colpostat segment, 25mm diameter for three-channel Applicator Sets	GM11001000	FDA UDI	Class II	Active
Fixation screw with nut for Cervix Applicator Set	GM11005230	FDA UDI	Class II	Active
Mobius3D	4.0	FDA UDI	Class II	Active
Mobius3D	2.0.1	FDA UDI	Class II	Unknown
Titanium Colpostat Probe (left)	GM11006110	FDA UDI	Class II	Active
Velocity Medical Imaging Data Comparison Software	4.0	FDA UDI	Class II	Active
ONCOZENE 40um Oncozene 2mL - US	10420-US1	FDA UDI	Class II	Active
Ethos Radiotherapy System	3.1	FDA UDI	Class II	Active
Leak Stop Channel Marker - Channel 19 - 25 pack	Channel 19	FDA UDI	Class II	Active
Varian Collimator Accessories Lead wedge set upper (JITKIT)	10004249721	FDA UDI	Class II	Active
Small Component Box	GM11012300	FDA UDI	Class II	Unknown
Titanium intrauterine probe, 30 degrees angle, Titanium	GM11006690	FDA UDI	Class II	Active
Varian AI Segmentation	1.0	FDA UDI	Class II	Active
ONCOZENE 40um Oncozene 3mL - US	10430-US1	FDA UDI	Class II	Active
SynchroWave ST Antenna	22-17025-320	FDA UDI	Class II	Active
Varian Ethos Treatment Management	2.0	FDA UDI	Class II	Active
Leak Stop Channel Marker - Channel 2 - 25 pack	Channel 2	FDA UDI	Class II	Active
Varian Collimator Accessories Lead wedge set lower (JITKIT)	10004249720	FDA UDI	Class II	Active
OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm	OMM 11/10	FDA UDI	Class II	Active
Eclipse Treatment Planning System for External Beam Radiation Therapy	15.1	FDA UDI	Class II	Active
Smart Segmentation Knowledge Based Contouring	15.1	FDA UDI	Class II	Active
OmniBone Power Driver	SP-002-1F	FDA UDI	Class II	Active
ARIA Oncology Information System - Radiation Oncology	13.7	FDA UDI	Class II	Active
Beacon Care Package - Prostate	ASM0094-003	FDA UDI	Class II	Active
TrueBeam	3.0	FDA UDI	Class II	Active
Varian DoseLab Pro	7.0	FDA UDI	Class II	Active
ARIA Radiation Therapy Management Software	13.7	FDA UDI	Class II	Active
Titanium forceps clamping mechanism	GM11006800	FDA UDI	Class II	Active
Varian Ethos Treatment Planning	1.0	FDA UDI	Class II	Active

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FDA Recalls (61)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 12, 2019	Z-1899-2020	—	terminated	After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.
Dec 26, 2018	Z-0771-2019	—	terminated	There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation. For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R is erroneous compared to the correct range R: 1) X=Y; R =R (R is correct); 2) XY R >R (R is too big).
Aug 20, 2018	Z-0005-2019	—	terminated	Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
Aug 20, 2018	Z-0004-2019	—	terminated	Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
Dec 2, 2016	Z-0990-2017	—	terminated	Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.
Sep 13, 2016	Z-0077-2017	—	terminated	Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
Jun 23, 2016	Z-2149-2016	—	terminated	Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
Jun 23, 2016	Z-2150-2016	—	terminated	Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
Jan 11, 2016	Z-0805-2016	—	terminated	When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
Sep 28, 2015	Z-0170-2016	—	terminated	An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.
May 18, 2015	Z-1829-2015	—	terminated	Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat
May 18, 2015	Z-1849-2015	—	terminated	After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).
Aug 18, 2014	Z-2654-2014	—	terminated	Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.
Jun 17, 2014	Z-2567-2014	—	terminated	Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
Apr 30, 2014	Z-0526-2015	—	terminated	Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc tion assembly cable and the ground stud on the lid of the High Voltage Module.
Mar 20, 2014	Z-1502-2014	—	terminated	Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
Nov 18, 2013	Z-0552-2014	—	terminated	An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
Oct 24, 2013	Z-0439-2014	—	terminated	This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
Aug 9, 2013	Z-0065-2014	—	terminated	The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
Sep 28, 2012	Z-0607-2013	—	terminated	The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Apr 12, 2012	Z-0760-2013	—	terminated	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Apr 12, 2012	Z-0759-2013	—	terminated	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Jan 25, 2012	Z-1385-2012	—	terminated	Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.
Jan 5, 2012	Z-1200-2012	—	terminated	Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
Jan 5, 2012	Z-1199-2012	—	terminated	Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
Mar 17, 2011	Z-3204-2011	—	terminated	An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.
Aug 11, 2010	Z-3103-2011	—	terminated	Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.
Jul 20, 2010	Z-0821-2011	—	terminated	The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option.
May 20, 2010	Z-0282-2012	—	terminated	The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.
Mar 1, 2010	Z-0325-2012	—	terminated	VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.
Sep 30, 2008	Z-0328-2012	—	terminated	Plastic needle tip could possibly crack or separate.
Sep 30, 2008	Z-0326-2012	—	terminated	Plastic needle tip could possibly crack or separate.
Sep 30, 2008	Z-0327-2012	—	terminated	Plastic needle tip could possibly crack or separate.
Aug 5, 2008	Z-0295-2012	—	terminated	GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
Mar 12, 2008	Z-2081-2008	—	terminated	Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.
Oct 2, 2007	Z-0720-2008	—	terminated	Incorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.
Sep 26, 2007	Z-0554-2008	—	terminated	Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered
Sep 10, 2007	Z-0545-2008	—	terminated	The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.
Sep 10, 2007	Z-0544-2008	—	terminated	Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.
Jun 25, 2007	Z-0213-2008	—	terminated	Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.
May 2, 2007	Z-1074-2007	—	terminated	The wedge tray may slip out of the Clinac interface mount during gantry rotation.
Apr 18, 2007	Z-1195-2007	—	terminated	Patient positioning errors may occur because of mechanical variations during product installation.
Mar 9, 2007	Z-0978-2007	—	terminated	A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.
Sep 21, 2006	Z-0304-2007	—	terminated	Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
Sep 11, 2006	Z-0486-2007	—	terminated	Medical device for patient treatment does not meet electrical safety standards.
Sep 11, 2006	Z-0487-2007	—	terminated	Medical device for patient treatment does not meet electrical safety standards.
Aug 31, 2006	Z-0194-2007	—	terminated	The chain holding the device gantry in position may break.
Jun 6, 2006	Z-1206-06	—	terminated	Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
May 1, 2006	Z-1399-06	—	terminated	Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
May 1, 2006	Z-1398-06	—	terminated	Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
May 1, 2006	Z-1269-06	—	terminated	Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
May 1, 2006	Z-1270-06	—	terminated	Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
May 1, 2006	Z-1268-06	—	terminated	Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
Nov 23, 2005	Z-0393-06	—	terminated	The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.
Apr 14, 2005	Z-0921-05	—	terminated	A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
Jun 24, 2004	Z-1314-04	—	terminated	a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.
May 27, 2004	Z-1084-04	—	terminated	An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1
May 4, 2004	Z-0976-04	—	terminated	Manufacturer of brachytherapy instrument issued a Customer Technical Bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners.
Feb 6, 2004	Z-0582-04	—	terminated	Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
Jan 31, 2003	Z-0633-03	—	terminated	The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
Apr 11, 13	Z-1324-2013	—	terminated	Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.