[Recalled] 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 radiation treatment is ind
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | 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 radiation treatment is indicated. |
|---|---|
| Brand / manufacturer | Viewray Incorporated |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1954-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 07 May 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The software was failing to determine new patient locations if imaging is not enabled during treatment.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Viewray Incorporated
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.