Reported Sep 12, 2012 · Terminated
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and…
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?
- Brand nameRayStation
- Generic nameTreatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. 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
- Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.
- Amount recalled
- 19 units
Where it was sold
Why it was recalled
The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio
This product could cause temporary or reversible health problems — stop using it.
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