Z-0481-2021 Class II Terminated
FDA device recall Z-0481-2021 was initiated by Viewray, Inc. on October 20, 2020 and is designated Class II. 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. The recall status is terminated (terminated October 13, 2023). Affected quantity: 3 systems.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2020
- Initiation Date
- October 20, 2020
- Termination Date
- October 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 systems
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.
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.
Code Information
All Lots/Serial Numbers