RaySearch Laboratories issued an urgent field safety notice in Europe to warn on an issue with the dose calculation for the Siemens (NYSE:SI) virtual wedge in several of RaySearch’s RayStation treatment planning systems.
The affected RayStation models listed in the safety notice out of Germany included RayStation 4.0, 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, RayStation/RayPlan 9A and RayStation/RayPlan 9B.
RaySearch Laboratories said that the issue has not caused any patient mistreatment or other incidents, as far as the company has been informed.
Because the machines have certain physical limitations, there is a maximum field opening for Siemens’ virtual wedge fields that is recommended by the linear accelerator (LINAC) vendor. That opening is more restricted in the wedged direction than the maximum field opening without a wedge. The issue found in the RayStation products created a high dose plateau region that extends beyond the recommended field size.
The company intends to add enhancements to its next major version of the product designed to prevent RayStation/RayPlan models from creating plans that would result in the high dose plateau region. That new version is scheduled for market release in May.
Customers are urged not to use Siemens’ virtual wedge fields outside the recommended specification. However, if customers wish to continue to use the affected versions of the RayStation/RayPlan products, it is suggested that they maintain awareness of the warning. RaySearch intends to give customers the option to upgrade to the new version once it is available for clinical use.
