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Varian Medical Systems Oncology Systems

Varian Medical Systems Oncology Systems Recalls

All product recalls associated with Varian Medical Systems Oncology Systems.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Mar 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 51 recalls

Varian Medical Systems Oncology Systems: Varis Aria Radiation Oncology Version 8.1, manufactured b...

Dose delivery may be altered after import from a third party planning system during radiation therapy.

FDAMay 21, 2008Nationwide• Varian Medical Systems Oncology Systems

Varian Medical Systems, Inc.: VariSource CT/MR Ring & Tandem Applicator Set, catalog # ...

Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.

FDAMar 12, 2008Nationwide• Varian Medical Systems, Inc.

Varian Medical Systems Oncology Systems: Eclipse Treatment Planning System, Client 8.1.18 and DCF ...

A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.

FDA

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Page 2 of 3Next

Feb 13, 2008

AL, AZ, AR +24 more

• Varian Medical Systems Oncology Systems

Varian Medical Systems Oncology Systems: High-Definition 120 MultiLeaf Collimator, Medical charged...

Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.

FDAJan 30, 2008Nationwide• Varian Medical Systems Oncology Systems

Varian Medical Systems Oncology Systems: Acuity with Conebeam Computed Tomography; Radiation thera...

Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.

FDAJan 3, 2008CA, MA, PA• Varian Medical Systems Oncology Systems

Varian Medical Systems Oncology Systems: Varian Medical Systems On-Board Imager, Versions 1.0.15 a...

If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.

FDAJan 3, 2008AL, AK, AZ +35 more• Varian Medical Systems Oncology Systems

Varian Medical Systems Inc: Varian brand VARiS 1.4g (Medical Charged Particle Radiati...

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.

FDAOct 2, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian Real-Time Position Management System (RPM), A Resp...

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

FDASep 26, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

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.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

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.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Ximatron Digital Imaging (Ximavision), V 7.5.51 with Serv...

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.

FDAJun 25, 2007MO, NY• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian Medical Systems Clinac Medical Linear Accelerator....

The wedge tray may slip out of the Clinac interface mount during gantry rotation.

FDAMay 2, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian On-Board Imager Device versions 1.2 and 1.3, when ...

Patient positioning errors may occur because of mechanical variations during product installation.

FDAApr 18, 2007PR• Varian Medical Systems Inc

Varian Medical Systems Oncology Systems: FramelessArray software, Version 1.0. ; Medical Device fi...

Localization error; with planning data transferred to the Optical Guidance Platform via DICOM RT; The software incorrectly computes the center of the CT volume, resulting in a potential axial error ranging from 0.3 mm to 1.5 mm, affecting both Fractionated and Stereotactic Radiosurgery (SRS) Treatments

FDAMar 14, 2007IN• Varian Medical Systems Oncology Systems

Varian Medical Systems Inc: LINAC Scapel Treatment Planning System, incorporating Fas...

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.

FDAMar 9, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: 4D Integrated Treatment Console and Varis 1.4g Medical Ch...

Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.

FDASep 21, 2006Nationwide• Varian Medical Systems Inc

Varian Medical Systems: GammaMed 12i radionuclide applicator systems, distributed...

Medical device for patient treatment does not meet electrical safety standards.

FDASep 11, 2006AZ, GA, IL +2 more• Varian Medical Systems

Varian Medical Systems: GammaMed 12it radionuclide applicator system, Varian Medi...

Medical device for patient treatment does not meet electrical safety standards.

FDASep 11, 2006AZ, GA, IL +2 more• Varian Medical Systems

Varian Medical Systems Inc: Clinac High Energy Medical Linear Accelerator, Medical Ch...

The chain holding the device gantry in position may break.

FDAAug 31, 2006Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian brand Clinac C-series Pendant Radiation delivery s...

Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.

FDAJun 6, 2006Nationwide• Varian Medical Systems Inc