RayStation 2024B treatment planning recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a calculated radiation dose that is not invalidated when it should be can be used for planning, and no injuries are reported.
Plain-English summary
RayStation/RayPlan, a radiation therapy treatment planning system, model 16.0.0, software version RayStation 2024B, is being recalled by RaySearch Laboratories AB.
The record states there is a potential for the invalidation for calculated radiation dose not to work as intended for certain Regions of Interest (ROIs). The issue occurs for some ROIs which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
The record's quantity field reads 0, so no unit count is given here. Rather than naming territories, the record refers to attached distribution lists, 'Distribution list 167168 US - updated' and 'Distribution list 167168 OUS'. UDI, GTIN and serial numbers are recorded in the enforcement record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Sites should follow RaySearch's instructions.
The recalled product
- Product
- Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
- Manufacturer
- RAYSEARCH LABORATORIES AB
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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