Recall Z-0806-2016— Viewray Incorporated

Name: FDA recall Z-0806-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-24

Class II · Terminated

Class II FDA medical device recall by Viewray Incorporated, initiated 2015-12-24, terminated 2017-02-22. It names one FDA 510(k) clearance: K111862. Product: MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.. Reason: The system loaded a completion fraction in the incorrect order after a treatment interruption..

Recalling firm: Viewray Incorporated
Classification: Class II
Status: Terminated
Initiated: 2015-12-24
Terminated: 2017-02-22
Firm location: Oakwood Village, OH, United States

510(k) clearances named in this recall

1 on FDA's record

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 ViewRay Radiation Therapy System, VIEWRAY Inc.

Reason for recall

The system loaded a completion fraction in the incorrect order after a treatment interruption.

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