Viewray, Inc. recalls MRIdian Linac Radiation Therapy System, Model 20000.

Recall date

March 18, 2019

Source

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

Recall number

Z-1251-2019

FDA classification

Class II

Brand / firm

Viewray, Inc.

Sold / distributed

Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,

Why it was recalled

A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

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

What was recalled

MRIdian Linac Radiation Therapy System, Model 20000.