RAYSEARCH LABORATORIES AB recalls RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning…
- Recall date
- September 21, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0294-2019
- FDA classification
- Class II
- Brand / firm
- RAYSEARCH LABORATORIES AB
- Sold / distributed
- Nationwide
Why it was recalled
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
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