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 KPR
원인
Not properly labeling the manual switch for disabling positive beam limitation (pbl) located on the overhead tube support user interface as required.
조치
GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance.
AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Malta, Martinique (French), Netherlands, Norway, Palestine, Portugal, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and Yugoslavia,
제품 설명
GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. || The intended use of this product is to generate tomographic images of human anatomy.