Drug recall
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment…
FDA recall event 81269 · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Event ID | 81269 |
|---|---|
| Recall numbers | Z-0294-2019 |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Product type | Devices |
| Products | RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7. |
| Initiation date | Sep 21, 2018 |
| Report date | Nov 7, 2018 |
| Termination date | Jun 16, 2020 |
| 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: