Z-0856-2009

RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number...

Name: Z-0856-2009 RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number...
Creator: Accuray Inc
Published: 2008-10-30
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2008-10-30 / Terminated / root cause: manufacturing process

FDA source

Accuray Inc began a recall of RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA... on 2008-10-30. The reason FDA records is "Product may not be tensioned properly, potentially causing unexpected rotation or descent". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0856-2009
Status: Terminated
Initiated: 2008-10-30
Posted: 2009-01-14
Terminated: 2009-09-10
Recalling firm: Accuray Incorporated
Product: 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.
Product code: JAI Couch, Radiation Therapy, Powered
Reason for recall: Product may not be tensioned properly, potentially causing unexpected rotation or descent.
Root cause tag: manufacturing process
FDA 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 1-877-668-8667 or 1-408-716-4700 or [email protected].
Quantity in commerce: 13 units
Distribution: Worldwide Distribution --- including USA and countries of France and Turkey.
Product codes and lots: Model number 025007, system numbers C0158, C0078, C0141, C0160, C0128, C0178, C0179, C0152, C0110, C0113, C0130, C0060, and C0125.

Product code JAI

K042146Class IIRobocouch Patient Support SystemAccuray Incorporated / cleared 2004-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)