Recall Z-0734-2017 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
| Date | Dec 12, 2016 (initiated Nov 22, 2016) |
| Status | Terminated |
| Reason | Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1 0.6. |
| Root cause | Software design |
| Action | Accuray sent an Urgent Safety Advisory Notification letter dated November 22, 2016, to all affected customers. Letters alerted users to the issue and the sequence of events necessary for it to occur. Accuray reps will visit all sites to perform a software upgrade to correct the issue. For more information or any questions about this notification, please contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support. For further questions, please call (408) 716-4600. |
| Quantity | 40 affected devices |
| Distribution | Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122137 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated, Oct 26, 2012 |