Elekta Recalls

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

Hazard: 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.

Hazard: 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.

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

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

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

Hazard: 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.

Hazard: Potential for iGUIDE to incorrectly monitor the 3D position.

Hazard: 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.

Hazard: 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.

Hazard: There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.

Hazard: Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.

Hazard: 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.

Hazard: 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.

Hazard: In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

Hazard: 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.

Hazard: Order Status Remains Approved When Should Indicate Complete.

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

Hazard: 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.

Hazard: Potential for positional errors following automatic table movement (ATM).

Hazard: Potential for positional errors following automatic table movement (ATM).

Hazard: 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.

Hazard: 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.

Hazard: Incorrect PEC values.

Hazard: 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.

Hazard: 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.

Hazard: Incorrect dose after editing beam number an wedge angle.

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

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

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