Reported Apr 1, 2020 · Ongoing
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1,…
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 Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 -
- 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
- Systems with software versions
4.0.0.144.0.1.44.0.2.94.0.3.44.5.0.194.5.1.144.5.2.74.7.0.154.7.1.104.7.2.54.7.3.134.7.4.44.7.5.44.7.6.74.9.0.425.0.0.375.0.1.115.0.2.355.0.3.176.0.0.246.1.0.266.1.1.26.2.0.76.3.0.67.0.0.198.0.0.618.0.1.108.1.0.478.1.1.88.1.2.59.0.0.113 or 9.1.0.933
- Systems with software versions
- Amount recalled
- 1389 licenses
Where it was sold
Why it was recalled
Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
This product could cause temporary or reversible health problems — stop using it.
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