Drug recall
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
FDA recall event 67511 · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Event ID | 67511 |
|---|---|
| Recall numbers | Z-1308-2014 |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Product type | Devices |
| Products | RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. |
| Initiation date | Feb 6, 2014 |
| Report date | Apr 9, 2014 |
| Termination date | Feb 17, 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: