Z-0035-2012

CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch)...

Name: Z-0035-2012 CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch)...
Creator: Accuray Incorporated
Published: 2011-09-12
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2011-09-12 / Terminated / root cause: manufacturing process

FDA source

Accuray Incorporated began a recall of CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation... on 2011-09-12. The reason FDA records is "A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly". 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-0035-2012
Status: Terminated
Initiated: 2011-09-12
Posted: 2011-10-11
Terminated: 2012-02-27
Recalling firm: Accuray Incorporated
Product: CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Device Correction Letters were sent to all sites affected by the retrofit on September 12, 2011 via Fed Ex. The letter identified the affected product and the description of the potential problem. Customers were asked to inspect their Synchrony System by following the instructions provided. If the lower extension feels loose, customers should contact Accuray Customer Support immediately to schedule service of the system. The letter also states that all affected systems will be inspected and corrected, if necessary by Accuray to prevent the potential problem. Accuray Customer Support will contact customers to schedule the inspection. Questions or concerns regarding the issue should be directed to Accuray Customer Support at 1-877-8667 for US customers and 1-408-716-4700 for customers outside of the US, or [email protected].
Quantity in commerce: 236 total devices
Distribution: Worldwide Distribution
Product codes and lots: Model numbers 026429 and 028185. All units

Product code IYE

K102650Class IICyberknife Robotic Radiosurgery SystemAccuray Incorporated / cleared 2010-11-17

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)