Drug recall
RayStation 9B SP1. For radiation treatment planning.
FDA recall event 90498 · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Event ID | 90498 |
|---|---|
| Recall numbers | Z-1403-2022 |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Product type | Devices |
| Products | RayStation 9B SP1. For radiation treatment planning. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare. |
| Initiation date | Jun 1, 2022 |
| Report date | Jul 27, 2022 |
| Termination date | Oct 4, 2023 |
| City | Stockholm |
| Country | Sweden |
| FEI number | 3007774465 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: