Z-0853-2011

RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery...

Name: Z-0853-2011 RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery...
Creator: Accuray Inc
Published: 2009-07-21
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2009-07-21 / Terminated / root cause: design

FDA source

Accuray Inc began a recall of RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated... on 2009-07-21. The reason FDA records is "Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0853-2011
Status: Terminated
Initiated: 2009-07-21
Posted: 2011-01-11
Terminated: 2011-01-12
Recalling firm: Accuray Incorporated
Product: 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.
Product code: JAI Couch, Radiation Therapy, Powered
Reason for recall: Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified verbally about the issue when an inspection was scheduled.
Quantity in commerce: 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.
Product codes and lots: RoboCouch model 025007

Product code JAI

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)