Recall Z-0218-2015 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife 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 | Nov 14, 2014 (initiated Oct 31, 2014) |
| Status | Terminated |
| Reason | Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator. |
| Root cause | Software design |
| Action | Accuray sent an Urgent Safety Advisory Notification letter dated October 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the radiaiton field size (beam width) for each Iris setting to ensure that it matches the beam commissioning data in the MultiPlan System to within the stated tolerance of 0.2 mm. Customers with questions were instructed to contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solutions Center at www.accuray.com or call North Am |
| Quantity | 84 devices subject to correction. |
| Distribution | Worldwide Distribution - USA including CA, MS, FL, AZ, DC, TX, CO, CT, IL, WI, RI, NV, OK, MA, AL, NY, MO, NC, TN, PA, DE, NJ, MI, IN, KS, OH. Foreign distribution to Turkey, Switzerland, Spain, Saudi Arabia, Russia, Poland, Mexico and Korea, Italy, India, Greece, Germany, France, England, Canada, a |
| 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 |