RAYSEARCH LABORATORIES AB recalls RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a softwa…

Recall date

March 28, 2018

Source

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

Recall number

Z-2290-2018

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI.

Why it was recalled

The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.

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 Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.