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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

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