Recall Z-0828-2014 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
| Date | Jan 27, 2014 (initiated Jan 13, 2014) |
| Status | Terminated |
| Reason | Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122137 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated, Oct 26, 2012 |