Facility

VIEWRAY SYSTEMS, INC.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007546534
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2 Thermo Fisher Way Oakwood Village, OH, US 44146
Registration status	Active · expires 2026
Parent company	Viewray Systems, Inc. (owner-operator 10090487)
Brand names	MRIdian A3i System

Activity by year

Recalls (6)

Devices registered here (2)

System, Nuclear Magnetic Resonance Imaging
Product code LNH (opens in a new tab) · Class II · Radiology · 21 CFR 892.1000
Accelerator, Linear, Medical
Product code IYE (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

Class IITerminated2016-03-07
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initia…
Class IITerminated2015-12-24
The system loaded a completion fraction in the incorrect order after a treatment interruption.
Class IITerminated2015-08-27
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.
Class IITerminated2015-05-07
The software was failing to determine new patient locations if imaging is not enabled during treatment.
Class IITerminated2015-04-01
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Class IITerminated2015-01-15
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.

All facilities operated by Viewray Systems, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “VIEWRAY SYSTEMS, INC. (FEI 3007546534) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007546534-viewray-systems-inc/

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