Elekta

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

Malware attack

There have been reports of excessive heating in the MRL Gradient Connection Module.

potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.

A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.

Monaco is using the incorrect energy when optimizing and calculating dose.

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

Potential for iGUIDE to incorrectly monitor the 3D position.

When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.

The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.

If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.

There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.

Order Status Remains Approved When Should Indicate Complete.

Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.

Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.

Incorrect PEC values.

If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.

Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.

Incorrect dose after editing beam number an wedge angle.

Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

Cross profile for Varian 60 degree wedge shows "horns."

Edits to Particle field definition parameters may not be saved when the field definition window is saved.

Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.

Incorrect Dose when using the reset function.

When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.

In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.

When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.

If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.

When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.

Incorrect drug dosage due to "Age Limit" and patient weight data item issue.

First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.

Unintended update of Dose and MU and Incorrect Assignment of Bolus.

Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.

Incorrect CT to ED when using the Monaco Image Statistics Tool.

Incorrect CT to ED when using the Monaco Image Statistics Tool.

Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.

Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.

When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.

XVI can incorrectly calculate the target position of the treatment table.

A bug in the software prevents the iGUIDE software from logging off.

If screws are not properly tightened with a torque wrench they may become loose over time.

The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

Customers are resetting the default values outside recommended factory settings.

Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Customers are resetting the default values outside recommended factory settings.

It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems

Potential collision risk when using XVI and external beam shaping devices.

XVI can incorrectly calculate the target position of the treatment table.

When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.

When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.

Potential for clinical errors.

Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

Patient needs to be positioned as indicated by the treatment plan.

Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.

Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.

The Column rotation can accidentally be moved to a different position which in the locked position.

The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.

If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.