Home / Recalls / Viewray Incorporated / Z-0806-2016

Z-0806-2016 Class II Terminated

Recalled by Viewray Incorporated — Oakwood Village, OH

Recall Details

Product Type
Devices
Report Date
February 24, 2016
Initiation Date
December 24, 2015
Termination Date
February 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

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.

Distribution Pattern

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

Other recalls by Viewray Incorporated

  • Z-1309-2016 Class II — MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Deliver (March 7, 2016)
  • Z-0115-2016 Class II — MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereo (August 27, 2015)
  • Z-1954-2015 Class II — Treatment Planning and Delivery System Software version 3.6. ViewRay. Indica (May 7, 2015)
  • Z-2085-2015 Class II — Patient Handling System (Motion Control Software), Product Usage: Indicated (April 1, 2015)
  • Z-1580-2015 Class II — ViewRay System, Radiation Therapy System (January 15, 2015)