Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision
FDA device recall Z-2085-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Viewray Incorporated
- Reason for recall
- ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
- Action taken
- ViewRay sent a Customer Advisory Notification Letters dated April 1, 2015 to thier customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns regarding this issue, contact ViewRaylM Customer Support at support@viewray.com or call the ViewRaylM Customer Support center at 855-286-8875.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3
- Distribution
- US Nationwide Distribution in the states of CA, MO & WI
- Date initiated
- 2015-04-01
- Date posted
- 2015-07-16
- 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 |