version 4.7.1,Cl II RayStation 4.7

Company:RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 8/26/2015
Class lI:

PRODUCT

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. Recall Number Z-2457-2015

REASON
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.

RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, SE on 5/27/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
126 programs

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

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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