RAYSEARCH LABORATORIES AB recalls Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment…

Recall date

January 18, 2017

Source

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

Recall number

Z-1815-2017

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

Nationwide Distribution to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS, MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C.

Why it was recalled

An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 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