Z-1810-2009

CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured...

Name: Z-1810-2009 CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured...
Creator: Accuray Inc
Published: 2009-06-22
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2009-06-22 / Terminated / root cause: software

FDA source

Accuray Inc began a recall of CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for... on 2009-06-22. The reason FDA records is "Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1810-2009
Status: Terminated
Initiated: 2009-06-22
Posted: 2009-09-14
Terminated: 2011-01-05
Recalling firm: Accuray Incorporated
Product: CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
Root cause tag: software
FDA root cause: Software design
Action: Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue. For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or [email protected].
Quantity in commerce: 61 units
Distribution: Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.
Product codes and lots: All system Serial Numbers C128 and higher with 2005 edition Robot Controller.

Product code IYE

K072504Class IICyberknife Robotic Radiosurgery SystemAccuray Incorporated / cleared 2007-09-21

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)