Device recall
Z-0481-2021: ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC…
FDA device recall · Class II · Viewray, Inc.
Key facts
| Recall number (Z-number) | Z-0481-2021 |
|---|---|
| Recall event | 86661 |
| 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… |
| Product code | IYE |
| Recalling firm | Viewray, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2023 |
| 510(k) numbers | K111862 |
| FEI number | 3011233554 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database