Viewray Incorporated: Medical Device Recall in 2015 - (Recall #: Z-0115-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 27, 2015

Date Posted: October 21, 2015

Recall Number: Z-0115-2016

Event ID: 72166

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.

Status: Terminated

Product Quantity: 4 units

Code Information:

Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated