Recall Z-0771-2016 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: 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 | Feb 9, 2016 (initiated Jan 22, 2016) |
| Status | Terminated |
| Reason | The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient. |
| Root cause | Device Design |
| Action | Accuray sent an Urgent Safety Advisory Notification letters dated January 22, 2016 to all affected customers by trackable mail method. The letters identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgement form. For questions contact Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support |
| Quantity | 226 |
| Distribution | Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgiu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120233 | SYNCHRONY RESPIRATORY TRACKING SYSTEM Accuray Incorporated, Mar 9, 2012 |