Drug recall
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and…
FDA recall event 68162 · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Event ID | 68162 |
|---|---|
| Recall numbers | Z-1806-2014 |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Product type | Devices |
| Products | RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects… |
| Initiation date | Apr 25, 2014 |
| Report date | Jun 25, 2014 |
| Termination date | Jun 26, 2017 |
| 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: