Reported Jul 5, 2023 · Terminated
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B…
RaySearch America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RaySearch America Inc · 350 5th Ave Ste 5000 · New York, NY · 10118-0110
Is this the product you have?
- Radiation therapy software, RayStation standalone software treatment planning system
- Model numbers
8B8B SP18B SP29A9B9B SP110A10A SP1 and 10B
- Software versions
8.19.09.19.210.010.1
- Lot codes and dates
- UDI-DI07350002010129
- UDI-DI07350002010204
- UDI-DI07350002010235
- UDI-DI07350002010174
- UDI-DI07350002010266
- UDI-DI07350002010297
- UDI-DI07350002010303
- UDI-DI07350002010365
- UDI-DI07350002010310
- Amount recalled
- 5 systems
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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