RAYSEARCH LABORATORIES AB recalls RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The t…

Recall date

July 17, 2017

Source

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

Recall number

Z-0380-2018

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.

Why it was recalled

For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.

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 Product Usage: 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.