Medical device manufacturer, RaySearch Laboratories AB, has issued a medical device safety alert concerning its RayStation 2.5, RayStation 3.5, RayStation 4.0, RayStation 4.3 (InverseArc 1.0), RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7) [Build number: 2.5.1.89, 3.5.0.16, 3.5.1.6, 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, 7.0.0.19].

It has come to the manufacturer's attention that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields.

According to the manufacturer, the issue could lead to local under-dosage, potentially leading to in-effective treatment. It is the user's responsibility to validate the beam model for all clinically relevant fields before the system is used to create clinical treatment plans.

The manufacturer's assessment is that the necessary information is already present in the system labeling, but that it needs to be repeated and highlighted for all affected users, to avoid further mis-use. The safety warnings within the product documentation will be updated in the next version of RayStation/RayPlan.

The affected users are advised to do the following actions:

• Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans.
• Carefully review all beam model parameters before commissioning.
• Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields.
• Review any existing photon beam models to ensure that the actions above have been properly performed.
• Educate physics staff about the user responsibilities.

According to the local supplier, the affected product is distributed in Hong Kong.

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

Posted on 11 June 2018