Device Recall ABL 80 COOX SYSTEM

  • 모델명 / 제조번호(시리얼번호)
    Model Number: 393-841 all serial numbers are affected.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark Domestically to OH
  • 제품 설명
    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 || Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI || The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92009-1307
  • Source
    USFDA