Recall Z-1810-2009 ยท IYE Accelerator, Linear, Medical
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.
| Date | Sep 14, 2009 (initiated Jun 22, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated, Sep 21, 2007 |