Device recall
Z-2138-2021: RayStation (Radiation Treatment Planning System): RayStation 9A, 9B, 9B SP1…
FDA device recall · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Recall number (Z-number) | Z-2138-2021 |
|---|---|
| Recall event | 88258 |
| Product | RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297… |
| Product code | MUJ |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 20, 2024 |
| 510(k) numbers | K200487, K200569 |
| FEI number | 3007774465 |
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