Viewray, Inc. recalls MRIdian Linac Radiation Therapy System Model 10000 and 20000

Recall date

March 3, 2019

Source

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

Recall number

Z-0676-2020

FDA classification

Class II

Brand / firm

Viewray, Inc.

Sold / distributed

US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE

Why it was recalled

Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

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 10000 and 20000