Important Safety Alerts

Medical device manufacturer, RaySearch Laboratories AB, has issued a medical device safety alert concerning its RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, including all service packs.

• To determine if the version is affected, open the About RayStation dialog in the RayStation application and check if the build number reported there is "4.0.0.14", "4.0.3.4", "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", or "10.0.0.1154"

The Field Safety Notice (FSN) concerns an issue found with the DICOM import in the affected RayStation. If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI. The imported RT Structure Set must be corrupt for the bug to be triggered, i.e., the referenced ROI/POI must not exist in the imported RT Structure Set. According to the manufacturer, the issue has not caused any patient mistreatment or other incidents. However, the users must be aware of the following information to avoid incorrect ROI or POI references during treatment planning.

The references from a RT Plan/RT Ion Plan to a RT Structure Set that can be affected by this issue are bolus ROIs and prescription ROIs or POIs. Material override and other ROI or POI properties are not affected by this bug. If the RT Plan/RT Ion Plan, RT Structure Set and CT set are imported all at the same time, the incorrect references can only be set up to an ROI or a POI that does not have any definition on the CT set. This means that the ROI contours or the POI coordinates of the incorrectly referenced ROI or POI would not be defined. If the CT set is imported first and some ROIs/POIs are defined before importing the RT Plan/RT Ion Plan and RT Structure Set, the incorrectly referenced ROI/POI could be defined on the CT.

According to the manufacturer, users are instructed to do the following actions:

• Do not exclude the prescription ROI or POI when exporting from RayStation with the "Exclude from export" option.
• If an RT Structure Set where it is not certain that all referenced bolus and prescription ROIs or POIs are present is imported to RayStation, make sure to check that any intended references to bolus and prescription are correct after import.
• Educate planning staff and all users about this workaround.
• Inspect the product and identify all installed units with the affected software version numbers.

This issue will be resolved in the next version of RayStation, scheduled for market release in November 2020 (subject to market clearance in some markets). If users wish to continue using versions of RayStation affected by this issue, they must maintain awareness of the FSN. Alternatively, users can choose to upgrade to the new version once it becomes available for clinical use.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

For details of the affected issue, users are advised to refer to the manufacturer's FSN.

Posted on 12 October 2020