MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian Syst
FDA device recall Z-1309-2016 · posted 2016-03-31 · Terminated
Recall details
- Recalling firm
- Viewray Incorporated
- Reason for recall
- When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
- Action taken
- ViewRay sent an Urgent Device Correction letter dated March 7, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed 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
- Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
- Date initiated
- 2016-03-07
- Date posted
- 2016-03-31
- 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 |