RAYSEARCH LABORATORIES AB recalls RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9)…
- Recall date
- November 20, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1930-2019
- FDA classification
- Class II
- Brand / firm
- RAYSEARCH LABORATORIES AB
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
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 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
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