Medical device manufacturer, RaySearch Laboratories AB (publ), has issued a medical device safety alert concerning its RayStation. The details of the affected products are as follow:

• The products affected by this notice are sold under the trade names RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan7, RayStation/RayPlan 8A, RayStation/RayPlan 8B and RayStation/RayPlan 9A.
• To determine if the version users are using is affected, open the About RayStation/RayPlan dialog in the RayStation/RayPlan 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", "4.5.0.19","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", or "9.0.0.113".

This notice concerns an issue found with static arc planning in the affected products. According to the manufacturer, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.

Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. This may happen in the following scenarios:

• When editing or viewing a static arc beam with a cone using the Edit beam dialog. The bug is triggered when closing the Edit beam dialog with OK, even if no changes were made in the dialog.
• When editing the aperture of a static arc beam using the Polygon tool or the Rectangular Field tool.

If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported. After recalculation the dose will be correct, but the beam weighting can be different than it was before the beam was edited, even if the beam weights were clamped (locked) in the Beam Weighting tab.

Affected users should aware that the MU of static arc beams may change unexpectedly when using the Edit beam dialog or when editing the beam aperture. Users should always review the final dose before approving a plan for treatment, and should educate planning staff and all users about this workaround.

This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in December 2019 (subject to market clearance in some markets). If users wish to continue using versions of RayStation/RayPlan affected, all users must maintain awareness of this notice. 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 affected products, please contact your supplier for necessary actions.

Posted on 21 November 2019