Medical device manufacturer, RaySearch Laboratories, has issued a medical device safety alert concerning its following products:
- RayStation 4.0, RayStation 4.3 (InverseArc), RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan 7, RayStation/RayPlan 8A, RayStation/RayPlan 8B and RayStation/RayPlan 9A
- To determine if the version users are using is affected, open the About RayStation dialog in the RayStation application and check if the build number reported there is "4.0.0.14", "4.0.1.4", "4.0.2.9", "4.0.3.4", "4.3.0.14", "4.5.0.19", "4.5.1.14", "4.5.2.7", "4.7.0.15", "4.7.1.10", "4.7.2.5", "4.7.3.13", "4.7.4.4", "4.7.5.4", "4.9.0.42", "5.0.0.37", "5.0.1.11", "5.0.2.35", "6.0.0.24", "6.1.0.26", "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" and "9.0.0.113"
According to the manufacturer, the Field Safety Notice (FSN) concerns three issues found with the affected products:
- The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries.
- Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves.
- SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.
These issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the information detail in the FSN (RSL-D-61-406) to avoid incorrect dose calculations during treatment planning.
Affected users are instructed to take the following actions:-
- Do not use the options 'Map ROI(s)' or 'Map ROI(s) reversed', only available by right-clicking in the ROI list. Instead, use the Copy ROI geometries dialog available in the Structure Definition module or the Map ROIs dialog available in the Deformable Registration module. l
- Be aware that the Elekta guard leaf setting from RayStation may be overridden by the R&V system or TCS. Affected users should contact the suppliers of their R&V system and TCS for more information. Scripting can be used to position the guard leaves according to the settings of the delivery system to avoid the overrides.
- Do not use the beam.GetSSD() scripting method. If needed in scripting, see RayCommunity.
- Do not use the SSD value displayed in the DRR in the plan report or exported DRR. Instead, use the SSD value displayed in the Beam data section of the plan report.
- Educate planning staff and all users about these workarounds.
- Inspect product and identify all installed units with the above software version number(s).
The Map ROI issue will be resolved in a future version of RayStation, scheduled for market release in May 2020. The Elekta guard leaves issue will be resolved in a future version of RayStation, scheduled for market release in May 2020. The SSD issue will be resolved in the next version of RayStation, scheduled for market release in December 2019.
If affected users wish to continue using versions of RayStation affected, all users must maintain awareness of the FSN. Alternatively, affected users can choose to upgrade to the new version once it becomes available for clinical use.
According to the manufacturer, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 December 2019