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
Fluoroscopic X-ray system - Product Code JAA
원인
The precision rxi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
조치
GE Field Engineers will visit affected customers to make correction.
Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand, and Venezuela.
제품 설명
GE Precision RXi Digital remote X-Ray Imaging R&F; System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA || The product is used for performing general R&F;, radiology, fluoroscopy, interventional and angiography procedures/applications.