Device recall
Z-2348-2020: RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For…
FDA device recall · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Recall number (Z-number) | Z-2348-2020 |
|---|---|
| Recall event | 85723 |
| Product | RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. |
| Product code | MUJ |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2021 |
| 510(k) numbers | K190387 |
| FEI number | 3007774465 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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