VARIAN MEDICAL SYSTEMS INC
TRUEBEAM · General Hospital
510(k) Clearances (10)
Substantially Equivalent
Substantially Equivalent
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Recalls (10)
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].
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].
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.
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.
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.
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.
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.
Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.
The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.
UDI Registrations (7)
MAUDE Adverse Events (10)
FDA Classification (66)
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