Home / Recalls / Viewray Incorporated / Z-0115-2016

Z-0115-2016 Class II Terminated

Recalled by Viewray Incorporated — Oakwood Village, OH

Recall Details

Product Type
Devices
Report Date
October 21, 2015
Initiation Date
August 27, 2015
Termination Date
June 9, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Reason for Recall

ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

Distribution Pattern

US Distribution to the states of : CA, MO and WI., and Internationally to Korea.

Code Information

Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 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-0806-2016 Class II — MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. (December 24, 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)