Recall Z-0676-2020— Viewray, Inc.

Name: FDA recall Z-0676-2020
Creator: U.S. Food and Drug Administration
Published: 2019-03-03

Class II · Terminated

Class II FDA medical device recall by Viewray, Inc., initiated 2019-03-03, terminated 2021-04-28. It names 2 FDA 510(k) clearances: K170751, K111862. Product: MRIdian Linac Radiation Therapy System Model 10000 and 20000. Reason: Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system..

Recalling firm: Viewray, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-03
Terminated: 2021-04-28
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K170751 — MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated·cleared 2017-06-07
K111862 — VIEWRAY SYSTEMViewray, Incorporated·cleared 2012-05-22

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 10000 and 20000

Reason for recall

Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

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