Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precis
FDA device recall Z-1954-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- Viewray Incorporated
- Reason for recall
- The software was failing to determine new patient locations if imaging is not enabled during treatment.
- Action taken
- On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3
- Distribution
- Distributed in the states of CA, MO & WI.
- Date initiated
- 2015-05-07
- Date posted
- 2015-07-02
- Date terminated
- 2016-02-04
- Location
- Oakwood Village, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWRAY SYSTEM (K111862) | Viewray, Incorporated | 2012-05-22 |