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 y2 diaphragm block was found loose.
조치
Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.