Recall Z-1251-2019— Viewray, Inc.

Name: FDA recall Z-1251-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-18

Class II · Terminated

Class II FDA medical device recall by Viewray, Inc., initiated 2019-03-18, terminated 2022-06-16. It names one FDA 510(k) clearance: K170751. Product: MRIdian Linac Radiation Therapy System, Model 20000.. Reason: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur..

Recalling firm: Viewray, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-18
Terminated: 2022-06-16
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170751 — MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated·cleared 2017-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MRIdian Linac Radiation Therapy System, Model 20000.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.