Home / Recalls / Viewray Incorporated / Z-1954-2015

Z-1954-2015 Class II Terminated

Recalled by Viewray Incorporated — Oakwood Village, OH

Recall Details

Product Type
Devices
Report Date
July 8, 2015
Initiation Date
May 7, 2015
Termination Date
February 4, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Reason for Recall

The software was failing to determine new patient locations if imaging is not enabled during treatment.

Distribution Pattern

Distributed in the states of CA, MO & WI.

Code Information

Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102

Other recalls by Viewray Incorporated

  • Z-1309-2016 Class II — MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Deliver (March 7, 2016)
  • Z-0806-2016 Class II — MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. (December 24, 2015)
  • Z-0115-2016 Class II — MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereo (August 27, 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)