Device recall
Z-2039-2023: Radiation therapy software, RayStation standalone software treatment planning…
FDA device recall · Class II · RaySearch America Inc
Key facts
| Recall number (Z-number) | Z-2039-2023 |
|---|---|
| Recall event | 92441 |
| Product | Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. |
| Product code | MUJ |
| Recalling firm | RaySearch America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2023 |
| 510(k) numbers | K200569 |
| FEI number | 3010034862 |
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