FDAMay 27, 2015device

RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.

What to do

FDA enforcement status: Terminated

Brands named

raysearch laboratories abraysearchraysearch laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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