Reported Nov 20, 2013 · Terminated
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
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 · Sveavaegen 9 · Stockholm · N/A
Is this the product you have?
- Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
- Lot codes and dates
Software version and build numbers 3.0.0.2513.5.0.163.5.1.64.0.0.144.0.1.4
- Amount recalled
- 195 units domestically
Where it was sold
Why it was recalled
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
This product could cause temporary or reversible health problems — stop using it.
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