Events

GE Healthcare DatexOhmeda Aisys 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
    36057
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0021-2007
  • 사례 시작날짜
    2006-08-10
  • 사례 출판 날짜
    2006-11-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47879
  • 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
    Anesthesia Delivery System - Product Code BSZ
  • 원인
    Vaporizer shutdown with alarm-an intermittent leak in the aladin 2 cassette/aisys pneumatic interface (valves) may occur that will invoke an alarm state. when this occurs 'vaporizer failure' will appear on the aisys main display, with an accompanying audible alrm. delivery of anesthetic agent is halted; gas flow and ventilation are not affected.
  • 조치
    Firm mailed recall letters on August 10, 2006, to consignees telling them what to do if a failure occurred during system checkout or during use, as a short term solution. Later, GE representatives will make visits to each site for modification of the interface valve on each device, as the long term solution.

Device

GE Healthcare DatexOhmeda Aisys
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: ANAK00115, ANAH00114, ANAH00115, ANAH00116, ANAH00117, ANAH00124, ANAH00126, ANAJ00100, ANAJ00101, ANAJ00102, ANAJ00103, ANAJ00104, ANAJ00105, ANAJ00106, ANAJ00107, ANAJ00108, ANAJ00109, ANAJ00110, ANAJ00111, ANAJ00112, ANAJ00113, ANAJ00114, ANAJ00115, ANAJ00116, ANAJ00117, ANAJ00118, ANAJ00119, ANAJ00120, ANAJ00121, ANAJ00122, ANAJ00123, ANAJ00124, ANAJ00125, ANAJ00126, ANAJ00127, ANAJ00128, ANAJ00129, ANAJ00131, ANAJ00132, ANAJ00133, ANAJ00134, ANAJ00135, ANAJ00136, ANAJ00137, ANAJ00138, ANAJ00139, ANAJ00140, ANAJ00141, ANAJ00142, ANAJ00143, ANAJ00144, ANAJ00145, ANAJ00146, ANAJ00147, ANAJ00148, ANAJ00149, ANAJ00150, ANAJ00151, ANAJ00152, ANAJ00153, ANAJ00154, ANAJ00155, ANAJ00156, ANAJ00157, ANAJ00158, ANAJ00159, ANAJ00160, ANAJ00161, ANAJ00162, ANAJ00163, ANAJ00164, ANAJ00165, ANAJ00166, ANAJ00167, ANAJ00168, ANAJ00169, ANAJ00170, ANAJ00171, ANAJ00172, ANAJ00173, ANAJ00174, ANAJ00175, ANAJ00176, ANAJ00177, ANAJ00178, ANAJ00179, ANAJ00180, ANAJ00181, ANAJ00182, ANAJ00183, ANAJ00184, ANAJ00185, ANAJ00186, ANAJ00187, ANAJ00188, ANAJ00189, ANAJ00190, ANAJ00191, ANAJ00192, ANAJ00193, ANAJ00194, ANAJ00195, ANAJ00195, ANAJ00196, ANAJ00197, ANAJ00198, ANAJ00199, ANAJ00200, ANAJ00201, ANAJ00202, ANAJ00203, ANAJ00204, ANAJ00205, ANAJ00206, ANAJ00207, ANAJ00208, ANAJ00209, ANAJ00210, ANAJ00211, ANAJ00212, ANAJ00213, ANAJ00214, ANAJ00215, ANAJ00216, ANAJ00217, ANAJ00218, ANAJ00219, ANAJ00220, ANAJ00221, ANAJ00222, ANAJ00223, ANAJ00224, ANAJ00225, ANAJ00226, ANAJ00227, ANAJ00228, ANAJ00229, ANAJ00230, ANAJ00231, ANAJ00232, ANAJ00233, ANAJ00234, ANAJ00235, ANAJ00236, ANAJ00237, ANAJ00238, ANAJ00239, ANAJ00240, ANAJ00241, ANAJ00242, ANAJ00243, ANAJ00244, ANAJ00245, ANAJ00246, ANAJ00247, ANAJ00248, ANAJ00249, ANAJ00250, ANAJ00251, ANAJ00252, ANAJ00253, ANAJ00254, ANAJ00255, ANAJ00256, ANAJ00257, ANAJ00258, ANAJ00259, ANAJ00260, ANAJ00261, ANAJ00262, ANAJ00263, ANAJ00264, ANAJ00265, ANAJ00266, ANAJ00267, ANAK00100, ANAK00101, ANAK00102, ANAK00103, ANAK00104, ANAK00105, ANAK00106, ANAK00107, ANAK00108, ANAK00109, ANAK00110, ANAK00111, ANAK00112, ANAK00113, ANAK00114, ANAK00116, ANAK00117, ANAK00118, ANAK00119, ANAK00120, ANAK00121, ANAK00122, ANAK00123, ANAK00124, ANAK00125, ANAK00126, ANAK00127, ANAK00128, ANAK00129, ANAK00130, ANAK00131, ANAK00132, ANAK00133, ANAK00134, ANAK00135, ANAK00136, ANAK00137, ANAK00138, ANAK00139, ANAK00140, ANAK00141, ANAK00142, ANAK00143, ANAK00144, ANAK00145, ANAK00146, ANAK00147, ANAK00148, ANAK00149, ANAK00150, ANAK00151, ANAK00152, ANAK00153, ANAK00154, ANAK00155, ANAK00156, ANAK00156, ANAK00157, ANAK00158, ANAK00159, ANAK00160, ANAK00161, ANAK00162, ANAK00163, ANAK00164, ANAK00165, ANAK00166, ANAK00167, ANAK00168, ANAK00169, ANAK00170, ANAK00171, ANAK00172, ANAK00173, ANAK00174, ANAK00175, ANAK00176, ANAK00177, ANAK00178, ANAK00179, ANAK00180, ANAK00181, ANAK00182, ANAK00183, ANAK00184, ANAK00185, ANAK00186, ANAK00187, ANAK00188, ANAK00189, ANAK00190, ANAK00191, ANAK00192, ANAK00193, ANAK00194, ANAK00195, ANAK00196, ANAK00197, ANAK00198, ANAK00199, ANAK00200, ANAK00201, ANAK00202, ANAK00203, ANAK00204, ANAK00205, ANAK00206, ANAK00207, ANAK00208, ANAK00209, ANAK00210, ANAK00211, ANAK00212, ANAK00213, ANAK00214, ANAK00215, ANAK00216, ANAK00217, ANAK00218, ANAK00219, ANAK00220, ANAK00221, ANAK00222, ANAK00223, ANAK00224, ANAK00225, ANAK00226, ANAK00227, ANAK00228, ANAK00229, ANAK00230, ANAK00231, ANAK00232, ANAK00233, ANAK00234, ANAK00235, ANAK00236, ANAK00237, ANAK00238, ANAK00239, ANAK00240, ANAK00241, ANAK00242, ANAK00243, ANAK00244, ANAK00245, ANAK00246, ANAK00247, ANAK00248, ANAK00249, ANAK00250, ANAK00251, ANAK00252, ANAK00253, ANAK00254, ANAK00255, ANAK00256, ANAK00257, ANAK00258, ANAK00259, ANAK00260, ANAK00261, ANAK00262, ANAK00263, ANAK00264, ANAK00265, ANAK00266, ANAK00267, ANAK00268, ANAK00269, ANAK00270, ANAK00271, ANAK00272, ANAK00273, ANAK00274, ANAK00275, ANAK00276, ANAK00277, ANAK00278, ANAK00279, ANAK00280, ANAK00281, ANAK00282, ANAK00283, ANAK00284, ANAK00285, ANAK00286, ANAK00287, ANAK00288, ANAK00289, ANAK00290, ANAK00291, ANAK00292, ANAK00293, ANAK00294, ANAK00295, ANAK00296, ANAK00297, ANAK00298, ANAK00299, ANAK00300, ANAK00301, ANAK00302, ANAK00303, ANAK00304, ANAK00305, ANAK00306, ANAK00307, ANAK00308, ANAK00309, ANAK00310, ANAK00311, ANAK00312, ANAK00313, ANAK00314, ANAK00315, ANAK00316, ANAK00317, ANAK00318, ANAK00319, ANAK00320, ANAK00321, ANAK00322, ANAK00323, ANAK00324, ANAK00325, ANAK00326, ANAK00327, ANAK00329, ANAK00330, ANAK00331, ANAK00332, ANAK00333, ANAK00334, ANAK00335, ANAK00336, ANAK00337, ANAK00338, ANAK00339, ANAK00340, ANAK00341, ANAK00342, ANAK00343, ANAK00344, ANAK00348, ANAK00349, ANAK00350, ANAK00351, ANAK00352, ANAK00353, ANAK00354, ANAK00355, ANAK00356, ANAK00357, ANAK00358, ANAK00359, ANAK00360, ANAK00361, ANAK00362, ANAK00363, ANAK00364, ANAK00365, ANAK00366, ANAK00367, ANAK00368, ANAK00369, ANAK00370, ANAK00371, ANAK00372, ANAK00373, ANAK00374, ANAK00375, ANAK00376, ANAK00377, ANAK00378, ANAK00379, ANAK00380, ANAK00381, ANAK00382, ANAK00383, ANAK00384, ANAK00385, ANAK00386, ANAK00387, ANAK00388, ANAK00389, ANAK00390, ANAK00391, ANAK00392, ANAK00393, ANAK00394, ANAK00395, ANAK00412, ANAK00413, ANAK00414, ANAK00415,
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,
  • 제품 설명
    GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
  • Manufacturer
    Datex - Ohmeda, Inc

Manufacturer

Datex - Ohmeda, Inc
  • 제조사 주소
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA