MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
FDA device recall Z-0806-2016 · posted 2016-02-12 · Terminated
Recall details
- Recalling firm
- Viewray Incorporated
- Reason for recall
- The system loaded a completion fraction in the incorrect order after a treatment interruption.
- Action taken
- ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call the ViewRay" Customer Support center at 855-286- 8875.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 5 units
- Distribution
- US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
- Date initiated
- 2015-12-24
- Date posted
- 2016-02-12
- Date terminated
- 2017-02-22
- Location
- Oakwood Village, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWRAY SYSTEM (K111862) | Viewray, Incorporated | 2012-05-22 |