FDA Device recall Z-0481-2021
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amp…
- FDA Device
- Class II
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class II recall of ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amp… by Viewray, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0481-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-20 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Viewray |
| Distribution | US |
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.
Identifiers
| code_info | All Lots/Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0481-2021%22
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