U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Accelerator, linear, medical - Product Code IYE
원인
Targeting accuracy out of specification, error alert does not render the system down, which may result in mistreatment in the wrong area.
조치
Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue.
For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.
Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.
제품 설명
CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. || Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.