Reported Feb 5, 2020 · Terminated
RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3,…
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 · Sveavagen 9 · Stockholm, N/A · N/A
Is this the product you have?
- RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
- Lot codes and dates
- Software Versions Numbers
4.0.0.144.0.1.44.0.2.94.0.3.44.3.0.144.5.0.194.5.1.144.5.2.74.7.0.154.7.1.104.7.2.54.7.3.134.7.4.44.7.5.44.9.0.425.0.0.375.0.1.11 5.0.2.356.0.0.246.1.0.266.1.1.26.2.0.76.3.0.67.0.0.198.0.0.618.0.1.108.1.0.478.1.1.88.1.2.59.0.0.113
- Software Versions Numbers
- Amount recalled
- 3114 Devices/Licenses
Where it was sold
Why it was recalled
Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.
This product could cause temporary or reversible health problems — stop using it.
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