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
X-ray system - Product Code JAA
원인
Automatic exposure control (aec) automatically resets allowing another exposure without requiring manual reset as specified in 21 cfr 1020.31 (a)(3)(iv).
조치
Correction to devices is being implemented through GEHC Field Modification Instructions.
within US: CO, IL, LA, MA, MI, NC, PA, SC,TN, VA. OUS to include: Austrailia, Belgium, Burkina Faso, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Italy, Republic of Korea, Lebanon, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Taiwan, Republic of China, United Kingdom
제품 설명
GE Precision RXi Digital Remote X-Ray Imaging R&F; System. The Precision RXi digital is a remote R&F; system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32cm or 40cm image intensifier. GE Healthcare