Reported Sep 23, 2015 · Terminated
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning…
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?
- Radiation Therapy Treatment Planning System software 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.
- Lot codes and dates
- software build numbers are 4.7.0.15 or 4.7.1.10
- Amount recalled
- 20 devices
Where it was sold
- Nationwide
- WA
Why it was recalled
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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