Reported Mar 18, 2020 · Terminated
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
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/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
- Lot codes and dates
- UDI 07350002010174
- Amount recalled
- 1 system in the U.S.
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
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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