Varian Medical Systems Recalls

Hazard: 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.

Hazard: 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) X<Y: R <R (R is too small) and 3) X>Y R >R (R is too big).

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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

Hazard: 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].

Hazard: 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].

Hazard: 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.

Hazard: 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.

Hazard: 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).

Hazard: 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

Hazard: 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&shy; tion assembly cable and the ground stud on the lid of the High Voltage Module.

Hazard: 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.

Hazard: Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.

Hazard: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Hazard: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Hazard: The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.