Device recall
Z-1104-2026: RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4…
FDA device recall · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Recall number (Z-number) | Z-1104-2026 |
|---|---|
| Recall event | 98117 |
| Product | RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System |
| Product code | MUJ |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K220141 |
| 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