Drug recall
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment…
FDA recall event 71477 · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Event ID | 71477 |
|---|---|
| Recall numbers | Z-2785-2015 |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Product type | Devices |
| Products | Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images |
| Initiation date | May 29, 2015 |
| Report date | Sep 23, 2015 |
| Termination date | Mar 13, 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: