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
The product has the potential for the extension coupling of the synchrony extension mounting hardware to become loose over time. the assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
조치
Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail customersupport@accuracy.com to schedule service.
Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan
제품 설명
CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA || A Radiation therapy device.