Recall Register

Viewray, Inc.: FDA recalls

FDA enforcement reports name Viewray, Inc. as the recalling firm in 5 events. The events have 6 product records. The recalls started from 2019 to 2021. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

5 events, newest first.

FDA enforcement events of Viewray, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
4 May 2021ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is…DeviceClass II1Terminated
20 Oct 2020ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision…DeviceClass II2Terminated
18 Nov 2019ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) softwareDeviceClass II1Terminated
18 Mar 2019MRIdian Linac Radiation Therapy System, Model 20000.DeviceClass II1Terminated
3 Mar 2019MRIdian Linac Radiation Therapy System Model 10000 and 20000DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Viewray, Inc.: events for each product type
TypeEvents
Device5
Viewray, Inc.: events in each class
ClassEvents
Class II5
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Viewray, Inc., by the year that the recall started. The largest year is 2019, with 3 events.

Official channels

Cite this page

Recall Register. Viewray, Inc.: FDA recalls. https://recallregister.com/firm/viewray-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Viewray, Inc. have?
Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Viewray, Inc.?
FDA event 87865, which the firm started on 4 May 2021. The first product in the record is: ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is…
How many FDA recalls of Viewray, Inc. have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.