FDA Medical Device Recalls (openFDA)
Accuray Inc: 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.
- Recall number
- Z-1810-2009
- Recalling firm
- Accuray Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-06-22
- Posted
- 2009-09-14
- Terminated
- 2011-01-05
- Reason
- Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
- 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 customersupport@accuray.com.
- Quantity
- 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.
- Lot, serial or model codes
- All system Serial Numbers C128 and higher with 2005 edition Robot Controller.
- 510(k) numbers
- ["K072504"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1000123585
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28