Device product
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.
Z-0481-2021
Product summary
- Firm
- Viewray, Inc.
- Event
- Event 86661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 systems
- Official record key
device-enforcement:Z-0481-2021
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.