Radiation therapy software, RayStation standalone software… recallZ-2039-2023 · RaySearch America Inc · initiated Jan 22, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from RaySearch America Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.
FDA root cause category: Software design
What the company is doing
Field Safety Notice 73474 was emailed January 22, 2021 to affected customers. The notice identifies affected RayStation models: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B running software versions RS 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Users are instructed not to use Create wall, Expand/Contract, or ROI algebra functions directly on ROIs created by the DL segmentation. Instead, convert the ROIs to contour or mesh representation before using the affected functions. Users are to confirm they read and understood the notice by replying to the email. Error fixed in RS 10B Service Pack 1 and corrected in the next version of RayStation.
Recall details
- Recall number
- Z-2039-2023
- Status
- Terminated
- Initiated by the company
- Jan 22, 2021
- Posted by the FDA
- Jun 29, 2023
- Recalling firm
- RaySearch America Inc
- Quantity
- 5 systems
- Product code
- MUJ
- FDA submissions
- K200569
- Distribution
- US: AZ, CA, GA & WA
Product description
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
Code information (models, lots, serial numbers)
UDI-DI: 07350002010129 UDI-DI: 07350002010204 UDI-DI: 07350002010235 UDI-DI: 07350002010174 UDI-DI: 07350002010266 UDI-DI: 07350002010297 UDI-DI: 07350002010303 UDI-DI: 07350002010365 UDI-DI: 07350002010310
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- RayStation 9Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment12 recalls0 reports
- RayStation 9B SP1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 10.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls1 report
- RayStation 8.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 8.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
- RayStation 8.1.2Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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