Viewray, Inc. recalls ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz…

Recall date

October 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0481-2021

FDA classification

Class II

Brand / firm

Viewray, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.