Reported Jun 1, 2016 · Terminated
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment…
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 Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
- Lot codes and dates
3.0.0.2513.5.0.163.5.1.64.0.0.144.0.1.44.0.2.94.0.3.44.5.0.194.5.1.144.5.2.74.7.0.154.7.1.104.7.2.54.7.3.13 or 4.7.4.4
- Amount recalled
- 1,264 Total units (552 units domestically & 711 units internationally)
Where it was sold
Why it was recalled
A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.
This product could cause temporary or reversible health problems — stop using it.
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