Device Recall S/5 Anesthesia Delivery Unit

  • 모델명 / 제조번호(시리얼번호)
    S/5 Anesthesia Delivery Unit serial numbers: 6028818, 6048768, 6048777, 6048778, 6048795, 6048797, 6048799, 6048808, 6048811, 6048812, 6048815, 6048827, 6067704, 6067706, 6085914, 6085926, 6085927, 6085929, 6085935, 6085937, 6086576, 6086577, 6086583, 6086585, 6086588, 6086589, 6086592, 6086593, 6086595, 6086596, 6086600, 6086601, 6086602, 6086603, 6086608, 6086610, 6086611, 6086612, 6086613, 6097355, 6097356, 6097357, 6097364.  A-FGC1 Units serial numbers: 6020250, 6044947, 6044950, 6044951, 6045113, 6045120, 6045122, 6045127, 6045138, 6045151, 40022777, 40100065, 40106020, 40114446, 40115565, 40119019, 40121119, 40149506, 40173259.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    World wide-(including the States of IA, CA, MI, FL, MI, TX, IL, WI, OH, and countries of Finland, Singapore, Austria, South Africa, Sweden, Israel, Norway, Taiwan, Germany, Turkey, Portugal, Italy, Switzerland, Great Britain, and France
  • 제품 설명
    Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Healthcare, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53718
  • Source
    USFDA