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All product recalls associated with Elekta, Inc..
Total Recalls
59
Past Year
2
Class I (Serious)
0
Most Recent
Sep 2025
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.
There have been reports of excessive heating in the MRL Gradient Connection Module.
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.
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.
Potential for iGUIDE to incorrectly monitor the 3D position.
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Incorrect CT to ED when using the Monaco Image Statistics Tool.
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.
There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.
New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.
Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.
It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
Radiation unit doors could close too fast on emergency exit.
Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image studies.