Events

DatexOhmeda Aestiva/5 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datex-Ohmeda Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    28936
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0967-04
  • 사례 시작날짜
    2004-04-16
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-11-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32837
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Apparatus, Gas-Scavenging - Product Code CBN
  • 원인
    Increased circuit pressure as a result of a misassembled aestiva/5 active gas scavenging system.
  • 조치
    Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.

Device

DatexOhmeda Aestiva/5
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers AMRG02807, AMRG02889 thru AMRG02899, AMRG02930, AMRG02937 thru AMRG02942, AMRG02955, AMRG02958, AMRG02967, AMRG02968, AMRG02969, AMRG02979 thru AMRG03005, AMRG03012 thru AMRG03014, AMRG03017, AMRG03018, AMRG03030, AMRG03057 thru AMRG03062, AMRG03072, AMRG03077, AMRG03080, AMRG03081, AMRG03084, thru AMRG03088, AMRG03115, AMRG03155, AMRG03156, AMRG03174, AMRG03180 thru AMRG03185, AMRG03198, AMRG03199, AMRG03201, AMRG03208, AMRG03209, AMRG03212 thru AMRG03215, AMRG03222 thru AMRG03224, AMRG03261 thru AMRG03270, AMRG03298 thru AMRG03306, AMRG03331 thru AMRG03347, AMRG03351 thru AMRG03353, AMRH00124, thru AMRH00140, AMRH00143, AMRH00151, AMRH00152, AMRH00163, AMRH00169, AMRH00169, AMRH00170, AMRH00174 thru AMRH00181, AMRH00184, AMRH00185, AMRH00190 thru AMRH00202, AMRH00232 thru AMRH00237, AMRH00243, AMRH00244, AMRH00246, AMRH00247, AMRH00259, thru AMRH00276, AMRH00290 thru AMRH00307, AMRH00309, thru AMRH00311, AMRH00328, AMRH00329, AMRH00363 thru AMRH00368, AMRH00376, AMRH00382, thru AMRH00387, AMRH00396 thru AMRH00399, AMRH00399, AMRH00429, AMRH00430, AMRH00433, thru AMRH00439, AMRH00445 thru AMRH00464, AMRH00468, AMRH00469, AMRH00472 thru AMRH00474, AMRH00497 thru AMRH00502, AMRH00511 thru AMRH00513, AMRH00538 AMRH00543, AMRH00561 thru AMRH00571 thru AMRH00587, AMRH00589 thru AMRH00591, AMRH00594, AMRH00597 thru AMRH00603, AMRH00605 thru AMRH00626, AMRH00628 thru AMRH00636, AMRH00651, AMRH00652, AMRH00655 thru AMRH00657, AMRH00659 thruAMRH00661, AMRH00663 thru AMRH00669, AMRH00671, AMRH00672, AMRH00674 thru AMRH00676, AMRH00682, AMRH00684, and AMRH00704 thru AMRH00717
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The affected units were distributed nationwide in the United States and worldwide.
  • 제품 설명
    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc
  • 제조사 주소
    Datex-Ohmeda Inc, One Ohmeda Dr. Box 7550, Madison WI 53707
  • Source
    USFDA