Device recall
Z-0850-2022: RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs…
FDA device recall · Class II · RaySearch America Inc
Key facts
| Recall number (Z-number) | Z-0850-2022 |
|---|---|
| Recall event | 89822 |
| Product | RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayStation 6/RayPlan 2 Service Pack… |
| Product code | MUJ |
| Recalling firm | RaySearch America Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K211867 |
| 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