Reported Dec 2, 2020 · Terminated
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0,…
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 standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 -
- Product UsageRayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs
- Lot codes and dates
- Software version numbers
4.0.0.144.0.3.44.5.1.144.7.2.54.7.3.134.7.4.44.7.5.44.7.6.74.9.0.425.0.1.115.0.2.355.0.3.176.0.0.246.1.1.26.2.0.76.3.0.67.0.0.198.0.0.618.0.1.108.1.0.478.1.1.8 8.1.2.59.0.0.1139.1.0.9339.2.0.48310.0.0.1154
- Software version numbers
- Amount recalled
- 2768
Where it was sold
- Nationwide
Why it was recalled
If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.
This product could cause temporary or reversible health problems — stop using it.
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