Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and
FDA device recall Z-0828-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
- Action taken
- Urgent Medical Device Correction notification letter were sent out beginning January 14, 2014 by trackable method. Letters describe potential problem and provide inspection instructions to be performed prior to use.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 302 devices; 149 in US, 153 out of US.
- Distribution
- Worldwide Distribution. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Colombia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, It
- Date initiated
- 2014-01-13
- Date posted
- 2014-01-27
- Date terminated
- 2014-11-25
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM (K122137) | Accuray Incorporated | 2012-10-26 |