Drug recall
ViewRay System, Radiation Therapy System
FDA recall event 71050 · Class II · Viewray Incorporated
Key facts
| Event ID | 71050 |
|---|---|
| Recall numbers | Z-1580-2015 |
| Recalling firm | Viewray Incorporated |
| Product type | Devices |
| Products | ViewRay System, Radiation Therapy System |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch… |
| Initiation date | Jan 15, 2015 |
| Report date | May 13, 2015 |
| Termination date | Sep 23, 2015 |
| City | Oakwood Village |
| State | OH |
| Country | United States |
| FEI number | 3007546534 |
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: