Device Recall GE Healthcare Prodigy; Prodigy Advanced

  • 모델명 / 제조번호(시리얼번호)
    a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365  b) Prodigy Advanced, Model Numbers: LU42361, LU42397
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, Morocco, Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.
  • 제품 설명
    GE Healthcare: || a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 || b) Prodigy Advanced, Model Numbers: LU42361, LU42397 || Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, 3030 Ohmeda Dr, Madison WI 53718-6704
  • 제조사 모회사 (2017)
  • Source
    USFDA