Viewray, Inc. recalls ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50

Recalled December 2, 2020 · FDA recall Z-0482-2021 · Viewray

Hazard

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. · FDA Class II

Units

35 units

Sold at

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.

Description

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.

Product

ViewRay MRIdian Linac System: Model No. 20000, 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.

Manufacturer(s)

Viewray, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →