Drug recall
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range…
FDA recall event 86661 · Class II · Viewray, Inc.
Key facts
| Event ID | 86661 |
|---|---|
| Recall numbers | Z-0481-2021, Z-0482-2021 |
| Recalling firm | Viewray, Inc. |
| Product type | Devices |
| Products | ViewRay MRIdian Linac System: Model No. 20000, 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 20, 2020 |
| Report date | Dec 2, 2020 |
| Termination date | Oct 13, 2023 |
| City | Mountain View |
| State | CA |
| Country | United States |
| FEI number | 3011233554 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: