Recall Z-0481-2021— Viewray, Inc.
Class II · Terminated
Class II FDA medical device recall by Viewray, Inc., initiated 2020-10-20, terminated 2023-10-13. It names one FDA 510(k) clearance: K111862. 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.. 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..
- Recalling firm
- Viewray, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-20
- Terminated
- 2023-10-13
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.