MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
FDA Recall #Z-0806-2016 — Class II — December 24, 2015
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.
Recalling Firm
Viewray Incorporated — Oakwood Village, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5 units
Distribution
US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
Code Information
Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated