Reported Apr 9, 2014 · Terminated
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
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?
- RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
- Lot codes and dates
- Model#: 4.30
- Version4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
- Amount recalled
- 19 units (16 units domestically & 3 units internationally)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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