Device Recall Helix

  • 모델명 / 제조번호(시리얼번호)
    System ID: 57503, 57584, 57588, 57711, 57727, 57734, 57815, 57873, 58826, 0828960002, 082426010006, 082426130005, 082426160008, 00243NUC09, 0090J, 0177A, 0201B, 0252A, 0272B, 0274B, 0279A, 0280A, 0286A, 030038NU04, 030151NU02, 030232NU04, 080019NU03, 210001NU01, 250565NUC2, 416586HELIX, 418589HELIX, 506739HELIX, 519464HELIX, 61420HELIX, A5110123, A5153605, AP2302NM01, B4213128, B5315316, CS1013NM01, FE8161EL18, IL1041NM01, IL1042NM02, IL1062NM02, M4148612, M4392002, MPX247EL09, NE4191EL15, PL1139NM01, SK1042NM01.
  • 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
    Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera || Product Usage: || The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
  • Manufacturer
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    all serial numbers are listed in Product 1.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of 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, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
  • 제품 설명
    Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
  • Manufacturer