Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated Recalled by Viewray Incorporated Due to The software was failing to determine new patient...

Date: May 7, 2015
Company: Viewray Incorporated
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Viewray Incorporated directly.

Affected Products

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.

Quantity: 3

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: CA, MO, WI

Affected (3 states)Not affected

About Viewray Incorporated

Viewray Incorporated has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report