Viewray, Inc. recalls ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning ex…

Recall date

May 4, 2021

Source

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

Recall number

Z-1836-2021

FDA classification

Class II

Brand / firm

Viewray, Inc.

Sold / distributed

International distribution only to the countries of France, Germany, Italy, and Switzerland.

Why it was recalled

Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

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

What was recalled

ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.