Reported Jun 25, 2014 · Terminated
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of…
Raysearch Laboratories Ab
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 LABORATORIES AB · Sveavaegen 9 · Stockholm, N/A · N/A
Is this the product you have?
- RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
- Lot codes and dates
- Software version 4.0.3.4
- Amount recalled
- 25 sites/245 units (US), 25 sites/124 units (foreign)
Where it was sold
Why it was recalled
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
This product could cause temporary or reversible health problems — stop using it.
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