Recall Z-0853-2011 ยท JAI Couch, Radiation Therapy, Powered
Accuray Inc
RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
| Date | Jan 11, 2011 (initiated Jul 21, 2009) |
| Status | Terminated |
| Reason | Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches. |
| Root cause | Device Design |
| Action | Consignees were notified verbally about the issue when an inspection was scheduled. |
| Quantity | 26 |
| Distribution | Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland. |
| FDA record | Open on fda.gov |