Drug recall
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery…
FDA recall event 71505 · Class II · Viewray Incorporated
Key facts
| Event ID | 71505 |
|---|---|
| Recall numbers | Z-1954-2015 |
| Recalling firm | Viewray Incorporated |
| Product type | Devices |
| Products | Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The software was failing to determine new patient locations if imaging is not enabled during treatment. |
| Initiation date | May 7, 2015 |
| Report date | Jul 8, 2015 |
| Termination date | Feb 4, 2016 |
| 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: