Z-0714-2011

CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by...

Name: Z-0714-2011 CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by...
Creator: Accuray Inc
Published: 2010-10-28
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2010-10-28 / Terminated

FDA source

Accuray Inc began a recall of CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment... on 2010-10-28. The reason FDA records is "If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0714-2011
Status: Terminated
Initiated: 2010-10-28
Posted: 2010-12-16
Terminated: 2011-04-01
Recalling firm: Accuray Incorporated
Product: CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment 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: If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.
FDA root cause: Other
Action: Accuray Inc., sent an "URGENT DEVICE CORRECTION" letter dated October 21, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to increase the size of the dose box to include CT volume, not just the contoured anatomy; recalculate dose at high resolution, and examine the treatment plan to ensure that applicable organs at risk are accounted for and all portions of the patient receive the desired level of doses. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA), +1-408-716-4700 (non-USA) or email: [email protected].
Quantity in commerce: 219 units
Distribution: USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela.
Product codes and lots: All versions

Product code IYE

K091999Class IICyberknife Robotic Radiosurgery SystemAccuray, Inc. / cleared 2009-09-18

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)