Recall Z-1098-2012 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation. Accuray Incorporated, Sunnyvale, CA. Treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is
| Date | Feb 23, 2012 (initiated Jan 16, 2012) |
| Status | Terminated |
| Reason | An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery. |
| Root cause | Software design |
| Action | Accuray sent an "URGENT DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides a work around to prevent the issue from happening. Contact Accuray Customer Support at 1-877-668-8667for questions regarding this notice. |
| Quantity | 207 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Korea, Hong Kong, China, Canada, Turkey, India, Russia, Italy, France, Belgium, Poland, Germany, Netherlands, United Kingdom, Spain, Greece, Saudi Arabia, Switzerland, Ukraine, Czech Republic, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091999 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc., Sep 18, 2009 |