Z-0909-2011

CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory...

Name: Z-0909-2011 CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory...
Creator: Accuray Inc
Published: 2009-03-16
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2009-03-16 / Terminated / root cause: design

FDA source

Accuray Inc began a recall of CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model... on 2009-03-16. The reason FDA records is "The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients...". 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-0909-2011
Status: Terminated
Initiated: 2009-03-16
Posted: 2011-01-18
Terminated: 2011-01-19
Recalling firm: Accuray Incorporated
Product: CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model Numbers: 026430, 028186, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
Root cause tag: design
FDA root cause: Device Design
Action: Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail [email protected] to schedule service.
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan
Product codes and lots: All units of these models.

Product code IYE

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)