Viewray, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0481-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ViewRay 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 radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Product Classification:

Class II

Date Initiated: October 20, 2020

Date Posted: December 2, 2020

Recall Number: Z-0481-2021

Event ID: 86661

Reason for Recall:

There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

Status: Terminated

Product Quantity: 3 systems

Code Information:

All Lots/Serial Numbers

Distribution Pattern:

Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.

Voluntary or Mandated:

Voluntary: Firm initiated