Device recall
Z-2206-2016: RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7…
FDA device recall · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Recall number (Z-number) | Z-2206-2016 |
|---|---|
| Recall event | 74618 |
| Product | RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions. |
| Product code | MUJ |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2017 |
| 510(k) numbers | K160093 |
| 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