Device Recall Optima NM/CT 640

  • 모델명 / 제조번호(시리얼번호)
    System ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
  • 제품 설명
    Optima NM/CT 640 || Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA