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 Support System is 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.
FDA Recall Z-0856-2009 · Posted 2009-01-14
Recalling FirmAccuray Inc
Recall StatusTerminated
Product CodeJAI
Date Initiated2008-10-30
Date Terminated2009-09-10
Product Quantity13 units
Reason for Recall
Product may not be tensioned properly, potentially causing unexpected rotation or descent.
Firm 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 1-877-668-8667 or 1-408-716-4700 or [email protected].
Root Cause
Process control
Distribution Pattern
Worldwide Distribution --- including USA and countries of France and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.