Recall Z-0629-2009 ยท IYE Accelerator, Linear, Medical
Accuray Inc
Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product 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.
| Date | Jan 17, 2009 (initiated Nov 14, 2008) |
| Status | Terminated |
| Reason | System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury. |
| Root cause | Software design |
| Action | An Urgent Advisory Notification letter dated November 14, 2008 was issued to all sites via Fed Ex. The letter identifies the issue and required actions. The user was instructed not to modify current extrapolation depth settings and to contact Accuray Incorporated Customer Support prior to making any changes. Please direct any questions or concerns regarding this issue to Accuray Incorporated Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (outside of USA) or customersupport@accuray.com. |
| Quantity | 4 units |
| Distribution | Nationwide Distribution. Product was distributed to 4 medical facilities in the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated, Sep 21, 2007 |