[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1
Pending LLM rewrite. Source: FDA_DEVICE Z-1106-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) 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 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
- Category
- Medical Device — Devices
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.
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