Recall Z-0856-2009 ยท JAI Couch, Radiation Therapy, Powered
Accuray Inc
RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA The CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The RoboCouch Patient Supp
| Date | Jan 14, 2009 (initiated Oct 30, 2008) |
| Status | Terminated |
| Reason | Product may not be tensioned properly, potentially causing unexpected rotation or descent. |
| Root cause | Process control |
| Action | All affected sites were notified of the potential problem via Customer Advisory Notice dated 30 October 2008. The letter states required actions that the customer should follow at the beginning of each treatment day. The tension of the belt drive and the support bolts in question will be inspected by Accuray Field Service personnel at the affected facilities. In addition, the preventive maintenance procedure will be updated to include regular inspection and replacement of the belt-drive. Any questions or concerns regarding this issue should be directed to Accuray Customer Support at 1-877- |
| Quantity | 13 units |
| Distribution | Worldwide Distribution --- including USA and countries of France and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM Accuray Incorporated, Sep 17, 2004 |