Z-1862-2008

Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model...

Name: Z-1862-2008 Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model...
Creator: Accuray Inc
Published: 2008-05-01
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2008-05-01 / Terminated / root cause: software

FDA source

Accuray Inc began a recall of Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and... on 2008-05-01. The reason FDA records is "Couch may move unexpectedly, which may result in patient impacting the linear accelerator". 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-1862-2008
Status: Terminated
Initiated: 2008-05-01
Posted: 2008-09-16
Terminated: 2010-11-30
Recalling firm: Accuray Incorporated
Product: Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is 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: Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
Root cause tag: software
FDA root cause: Software design
Action: All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted. Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or [email protected] for additional information.
Quantity in commerce: 105 units
Distribution: Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.
Product codes and lots: All models.

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)