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
Digital Fluoroscopic Imaging System - Product Code MQB
원인
Frozen image problems: during an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the dl (digital leader acquisition system) live monitor screen. in such cases, the system continued to send out x-rays without reporting an error message. the result was that the live imaging screen displayed an older "frozen" image until the operator released the.
조치
Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence.
Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.
Worldwide-USA including states of AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, SC, TN, TX, WA, WI, AK, AL, AZ, ,CT, DE, HI, ID, KS, KY, ME, MI, MN, MS, MT, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, UT, VA, WV, and Puerto Rico and countries of Hungary, Korea, Algeria, Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Finland, France, Georgia, Germany, Great Britain, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Turkey, and Venezuela.
제품 설명
GE Innova 4100 / 4100 IQ. , 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)