Reported Jun 3, 2015 · Terminated
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system…
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
Is this the product you have?
RaySearch RayStation 2.53.03.5 and 4.0Radiation
- Therapy Treatment Product UsageRayStation 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 (Build numbers) 2.5.1.893.0.0.2513.5.0.163.5.1.64.0.0.144.0.1.44.0.2.9or 4.0.3.4
- Amount recalled
- Domestic: 539 units
Where it was sold
- Nationwide
Why it was recalled
RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
This product could cause temporary or reversible health problems — stop using it.
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