Viewray Incorporated: Medical Device Recall in 2015 - (Recall #: Z-1954-2015)

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:

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.

Product Classification:

Class II

Date Initiated: May 7, 2015

Date Posted: July 8, 2015

Recall Number: Z-1954-2015

Event ID: 71505

Reason for Recall:

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

Status: Terminated

Product Quantity: 3

Code Information:

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

Distribution Pattern:

Distributed in the states of CA, MO & WI.

Voluntary or Mandated:

Voluntary: Firm initiated