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
Solid State X-Ray Imager - Product Code MQB
원인
Ge healthcare has become aware of an air kerma rate issue associated with a large equivalent patient thickness (ept) on the innova system that my impact patient safety. during a maximum air kerma rate (akr) calibration procedure check, ge healthcare found the akr calibration procedure does not exactly reflect the worst-case clinical usage of the product. this may result, when using large equival.
조치
Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
Nationwide Distribution -- United States including Puerto Rico and Guam.
제품 설명
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.