Device Recall Spectra Optia Apheresis System

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 1P00100 thru 1P00719
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.
  • 제품 설명
    Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. || The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Caridian BCT, Incorporated, 10811 W Collins Ave, Lakewood CO 80215-4440
  • 제조사 모회사 (2017)
  • Source
    USFDA