Recall – Radiation therapy system dose calculation error

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.