medical Class II Updated 2020-12-02

Viewray, Inc. recalls ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Su

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots/Serial Numbers
View official government recall

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