RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated

Recommended Action

Per FDA guidance

RaySearch issued Field Safety Notice, Medical Device Correction #84236 via E-mail on 22 September 2021. Letter states reason for recall, health risk and action to take: " Use the automatic tool in RayStation/RayPlan to create the External ROI. " When using a Support or Fixation ROI of tissue-like material (density around 1), extend this ROI a few millimeters inside the External ROI to cover the surface voxels of the patient. " If the Support or Fixation ROI differs significantly from the adjacent body tissue, an extra help ROI with material override set to a suitable material, for example, Skin, can be created inside the External ROI. The help ROI must have a width of a few millimeters and extend along the part of the patient surface connected to the Support or Fixation ROI. The same workflow can be used for Bolus ROIs in combination with electron beams. " If the bolus/support/fixation device is part of the CT data, an alternative solution is to include its structure inside the External ROI. In this case the structure should not be defined as a Bolus, Support or Fixation ROI, but as a normal ROI, by setting the ROI type to, for example Other . When included in the External ROI, the user can choose to use the CT densities or to apply a material override to the structure. If this method is applied for a bolus, the user must make sure that only the applicable beams pass through the structure. " For protons and light ions, the user should consider using a higher density uncertainty than normal in robust optimization for active scanning techniques and larger proximal and distal margins for the target in passive techniques, when shooting through a Fixation or Support ROI. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. This issue will be resolved in the next version of