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