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.

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.

On 10/20/2020, the firm, ViewRay, Inc, emailed an "Urgent Device Correction" notification to all affected consignees. In addition to informing consignees about the correction, the firm asked consignees to take the following actions.: 1. For Customer using TPDS software ver. 5.2.5 or earlier with optional 3 Plane imaging: - Do: Maintain a distance of at least 5 cm (~2) between the receive coil and the inner surface of the bore wall when using 3 Plane cin treatment imaging (Figure 3 & 4). - Do Not: Select 3 Plane cin treatment imaging if a distance of at least 5 cm (~2) cannot be maintained between the receive coil and the inner surface of the bore wall during treatment. 2. For Customer Using TPDS software ver. 5.3 or later with optional 8 fps enabled: - Do Not: Use 8 fps cin treatment imaging until further guidance is provided by ViewRay. - Do: Use 4 fps cin treatment imaging when treating a patient. 3. If you have any questions related to this letter, please contact ViewRay Customer Support at [email protected] or call +1 855-286-8875.