Cl II RayStation treatment planning systems

Date of Enforcement Report 7/27/2016
Class lI:


RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 — Radiation Therapy Treatment Planning System — designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.
Recall Number Z-2206-2016

An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. — To the best of the firm’s knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.

RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 7/1/2016 Voluntary: Firm Initiated recall is ongoing.

170 units

California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington


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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