Varian Medical Systems, Oncology Systems
Country not established
- Devices
- 4
- FDA recalls
- 102
At a glance
Market reach
- United States
- FDA recalls
What Varian Medical Systems, Oncology Systems makes
The company produces linear accelerators for radiation therapy, including single-energy models designed for precise external beam treatment. It also supplies proton therapy systems for targeted cancer treatment, such as the PT2 model, and verification tools like barcode conical collimator systems. Additional offerings include software platforms, such as Vitesse 3.0, for treatment planning and delivery optimization.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Barcode Conical Collimator Verification (Bccv) Ref K103394
Regimes: 510(k) Registry: 510(k)Varian Unique Single Energy Linear Accelerator Ref K101751
Regimes: 510(k) Registry: 510(k)Vitesse 3.0 Ref K123152
Regimes: 510(k) Registry: 510(k)PT2 Varian Proton Therapy System Ref K101294
Regimes: 510(k) Registry: 510(k)
FDA recalls
2013
- 26 Mar 2013 Z-1163-2013 Class II Terminated Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
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- 28 Jan 2013 Z-0867-2013 Class II Terminated The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
- 26 Mar 2013 Z-1163-2013 Class II Terminated Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
2012
- 5 Nov 2012 Z-0531-2013 Class II Terminated Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.
- 24 Sep 2012 Z-0187-2013 Class II Terminated An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
- 17 Aug 2012 Z-2462-2012 Class II Terminated Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.
- 14 Aug 2012 Z-2383-2012 Class II Terminated Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume.
- 2 Jul 2012 Z-2153-2012 Class II Terminated A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.
- 18 Jun 2012 Z-2041-2012 Class II Terminated Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect
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- 9 Apr 2012 Z-1495-2012 Not yet classified Terminated A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam.
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- 9 Apr 2012 Z-1617-2012 Not yet classified Terminated Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of.
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Show the 25 most recent of 102 recalls
2012
- 30 Jan 2012 Z-1161-2012 Not yet classified Terminated Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open.
- 30 Jan 2012 Z-1175-2012 Not yet classified Terminated An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning.
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- 30 Jan 2012 Z-1217-2012 Not yet classified Terminated An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to "Discard" that slice, an incorrect calculation of the isocenter location may result.
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- 16 Jan 2012 Z-1090-2012 Not yet classified Terminated When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose.
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- 16 Jan 2012 Z-1091-2012 Not yet classified Terminated When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose.
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2011
- 16 Dec 2011 Z-0713-2012 Unclassified (pre-2012) Terminated Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation.
- 12 Dec 2011 Z-0691-2012 Unclassified (pre-2012) Terminated Varian has discovered that on 4D Integrated Treatment Console and TrueBeam, the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO in RT Chart. The 4DITC algorithm adds dose for the control point at field edge, which should not be added according to the system specifications.
- 12 Dec 2011 Z-0715-2012 Unclassified (pre-2012) Terminated When multiple conical collimator treatment plans are scheduled to be treated in a session, the
Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the
4DITC. However, the name of the plan is not being updated correctly.
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- 12 Dec 2011 Z-0716-2012 Unclassified (pre-2012) Terminated When multiple conical collimator treatment plans are scheduled to be treated in a session, the
Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the
4DITC. However, the name of the plan is not being updated correctly.
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- 12 Dec 2011 Z-0736-2012 Unclassified (pre-2012) Terminated An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for the dose calculation. This will result in an incorrect dose distribution within Eclipse.
- 28 Nov 2011 Z-0483-2012 Unclassified (pre-2012) Terminated An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
- 28 Nov 2011 Z-0692-2012 Unclassified (pre-2012) Terminated An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
- 23 Nov 2011 Z-0516-2012 Unclassified (pre-2012) Terminated An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images.
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- 10 Nov 2011 Z-0945-2012 Unclassified (pre-2012) Terminated Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted.
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- 31 Oct 2011 Z-0364-2012 Unclassified (pre-2012) Terminated An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.
Frequently asked questions
How many devices does Varian Medical Systems, Oncology Systems have in the registry?
The registry currently lists 4 devices for Varian Medical Systems, Oncology Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Varian Medical Systems, Oncology Systems's devices?
Among its 4 most recently registered devices, Varian Medical Systems, Oncology Systems has devices listed in FDA 510(k) (4 devices).
What risk classes do Varian Medical Systems, Oncology Systems's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Varian Medical Systems, Oncology Systems's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Varian Medical Systems, Oncology Systems?
FDA recall records list 102 recalls initiated by Varian Medical Systems, Oncology Systems, the most recent initiated on 26 Mar 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Varian Medical Systems, Oncology Systems in the registry?
The most recently registered devices listed for Varian Medical Systems, Oncology Systems include BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV), VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR, VITESSE 3.0 and PT2 VARIAN PROTON THERAPY SYSTEM.