Recall Z-0382-2012 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the 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 11, 2012 (initiated Nov 7, 2011) |
| Status | Terminated |
| Reason | User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery. |
| Root cause | Labeling design |
| Action | Accuray sent a Urgent Medical Device Correction letter dated November 7, 2011, via Federal Express to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The information provided in this letter will be incorporated in user manuals shipped with the CyberKnife system. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at 1. (877) 668-8667 ( USA) 1. (408) 716-4700 ( non USA ) |
| Quantity | 30 |
| Distribution | Worldwide Distribution -- USA ( nationwide ) including the states of FL, TN, IL, NJ, CO, PA, MD, CA, MS, MN, SC, WA, OK, GA, AZ, and TX., and the countries of France and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091999 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc., Sep 18, 2009 |