Device recall
Z-1836-2021: ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product…
FDA device recall · Class II · Viewray, Inc.
Key facts
| Recall number (Z-number) | Z-1836-2021 |
|---|---|
| Recall event | 87865 |
| Product | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation… |
| Product code | MUJ |
| Recalling firm | Viewray, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 19, 2023 |
| 510(k) numbers | K102915, K181989 |
| 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