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
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
원인
A software defect - may result in a false indication and warning on the oec 9900 workstation and c-arm display that the x-ray tube anode is over-heated. this will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
조치
An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.