RAYSEARCH LABORATORIES AB recalls RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment…

Recall date

May 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2457-2015

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

Distributed in CO, IL, MI, NC, OH,TN, and WA.

Why it was recalled

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.

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 4.7, 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.