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
Multi-purpose X-ray system - Product Code JAA
원인
The precision mpi 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 visited affected customers to make the correction.
Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
제품 설명
GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA || The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.