Recall Z-1862-2008 ยท IYE Accelerator, Linear, Medical
Accuray Inc
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.
| Date | Sep 16, 2008 (initiated May 1, 2008) |
| Status | Terminated |
| Reason | Couch may move unexpectedly, which may result in patient impacting the linear accelerator. |
| 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 customersupport@accuray.com for additional information. |
| Quantity | 105 units |
| Distribution | Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated, Sep 21, 2007 |