Reported Jul 4, 2018 · Terminated
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a…
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
Is this the product you have?
- RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0
- Product UsageUsage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system
- Lot codes and dates
6.0.0.246.1.0.266.1.1.26.2.0.7 and 7.0.0.19
- Amount recalled
- 728
Where it was sold
Why it was recalled
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
This product could cause temporary or reversible health problems — stop using it.
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