Z-1008-2011

CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with...

Name: Z-1008-2011 CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with...
Creator: Accuray Inc
Published: 2009-12-29
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2009-12-29 / Terminated / root cause: manufacturing process

FDA source

Accuray Inc began a recall of CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5... on 2009-12-29. The reason FDA records is "If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk...". 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-1008-2011
Status: Terminated
Initiated: 2009-12-29
Posted: 2011-02-01
Terminated: 2011-02-11
Recalling firm: Accuray Incorporated
Product: CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended 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: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated December 29, 2009, to all customers. The letter described the product, problem, and action to be taken by the customers. The customers were instructed to verify correctness of the CT number to relative electron density and Mass Density Calibration curves. Note: A patch is being developed to address this issue. Accuray Customer Support will contact the customers regarding further resolution. If you have any questions or concerns regarding this issue, please contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non USA) or by email: [email protected].
Quantity in commerce: 71 units are subject to this action
Distribution: Worldwide Distribution: USA and countries including: Canada, Turkey, India, Italy, France, the Netherlands, the UK, India, Spain, Greece, Saudi Arabia, Switzerland, Germany and China.
Product codes and lots: All systems with multiplan tratment planning system software version 3.5

Product code MUJ

K091146Class IIModification to Cyberknife Robotic Radiosurgery SystemAccuray, Inc. / cleared 2009-05-01

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)