Reported Jan 24, 2018 · Terminated
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The…
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?
- RayStation Product Usageis 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
- Lot codes and dates
6.0.0.246.1.0.266.1.1.2 or 6.2.0.7
- Amount recalled
- 117 units
Where it was sold
Why it was recalled
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
This product could cause temporary or reversible health problems — stop using it.
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