Company: Viewray, Inc.
Date of Enforcement Report: 5/8/2019
Class II

PRODUCT

MRIdian Linac Radiation Therapy System, Model 20000.

Recall Number: Z-1251-2019

REASON

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

RECALLING FIRM/MANUFACTURER

Viewray, Inc on 3/18/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
17 devices

DISTRIBUTION

US Nationwide and International