RayStation 2023B and 2024A recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan models 14.0.0, 15.0.0 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 14.0.0, 15.0.0 and 15.1.3, software versions RayStation 2023B, RayStation 2024A and RayStation 2024A SP3, 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 lists 119 units. 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: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Affected units
- 119
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 (9)
- Lot Code: UDI: 0735000201055620230630
- 0735000201072320231213
- 0735000201088420250129 GTIN: 07350002010556
- 07350002010723
- 07350002010884 Serial Numbers: 14.0.0.3338
- 15.0.0.430
- 15.1.3.10 Software Revisions: RayStation 2023B
- RayStation 2024A
- RayStation 2024A SP3 Expiration Date: 2030-02-21
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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