RayStation 2024A treatment planning recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan models 15.2.0 and 15.1.3 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, models 15.2.0 and 15.1.3, software versions RayStation 2024A SP1 and RayStation 2024A SP2, 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: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
- Manufacturer
- RAYSEARCH LABORATORIES AB
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI: 0735000201076120240508
- 0735000201080820241217 GTIN: 07350002010761
- 07350002010808 Serial Numbers: 15.1.0.852
- 15.2.0.107 Software Revision: RayStation 2024A SP1
- RayStation 2024A SP2 Expiration Date: 2030-04-15
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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