Recall Register

Food, drugs, devices › Firms

Viewray Incorporated

FDA recalling firm · 6 enforcement events · 6 product records · 2015–2016 · OH

Viewray Incorporated has 6 FDA enforcement events on this register (6 product records) between 2015 and 2016: 6 device; the busiest year was 2015 with 5.

0% of its events are Class I; the most common class is Class II (6). 0 events are listed as ongoing; the recalling firm's address is in OH.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
7 Mar 2016MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicatedDeviceClass II1Terminated
24 Dec 2015MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.DeviceClass II1Terminated
27 Aug 2015MRIdian¿ 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.DeviceClass II1Terminated
7 May 2015Treatment 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.DeviceClass II1Terminated
1 Apr 2015Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.DeviceClass II1Terminated
15 Jan 2015ViewRay System, Radiation Therapy SystemDeviceClass II1Terminated

By type and class

Device6
Class II6

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Viewray Incorporated by year initiated.

Questions and answers

How many FDA recalls has Viewray Incorporated had?

6 enforcement events (6 product records) on this register, 2015–2016: 6 device.

Are any Viewray Incorporated recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Viewray Incorporated recalls?

6 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.