Reported Jan 2, 2019 · Terminated
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation…
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 · Sveavagen 9 · Stockholm · N/A
Is this the product you have?
RayStation 3.5RayStation 4.0RayStation 4.5RayStation 4.7RayStation 5RayStation 6RayStation 7 and RayStation 8A
- Lot codes and dates
- Software version number
3.5.0.163.5.1.64.0.0.144.0.1.44.0.2.94.0.3.44.5.0.194.5.1.144.5.2.74.7.0.154.7.1.104.7.2.54.7.3.134.7.4.44.7.5.45.0.0.375.0.1.115.0.2.356.0.0.246.1.0.266.1.1.26.2.0.77.0.0.198.0.0.61 or 8.0.1.10
- Software version number
- Amount recalled
- 69
Where it was sold
Why it was recalled
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
This product could cause temporary or reversible health problems — stop using it.
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