FDA-Device2015-09-02Class II
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.
RAYSEARCH LABORATORIES AB
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.
Sold states
Distributed in CO, IL, MI, NC, OH,TN, and WA.
Affected count
126 programs
Manufactured in
Sveavaegen 9, N/A, Stockholm, N/A, Sweden
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2457-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief