Events

Device Recall GE VOLUSON E8 ULTRASOUND SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ge Healthcare 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
    39400
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0113-2008
  • 사례 시작날짜
    2007-07-06
  • 사례 출판 날짜
    2007-11-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55383
  • 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
    ultrasound scanner - Product Code IYO
  • 원인
    When a spectrum of a pulsed wave doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a dicom station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.
  • 조치
    GE Healthcare sent customer letters on July 15, 2007 to affected customers. The letter included a short term mitigation recommendation and a long-term correction. The long-term correction will be software upgrade provided free of charge to all affected customers.

Device

Device Recall GE VOLUSON E8 ULTRASOUND SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: D00210, D00223, D00225, D00239, D00241, D00293, D00326, D00347, D00415, D00425, D00435, D00445, D00455, D00456, D00459, D00460, D00465, D00467, D00468, D00469, D00480, D00481, D00484, D00485, D00487, D00490, D00491, D00493, D00495, D00502, D00503, D00505, D00512, D00516, D00517, D00523, D00525, D00531, D00532, D00537, D00539, D00541, D00542, D00543, D00546, D00548, D00550, D00551, D00552, D00554, D00558, D00560, D00561, D00562, D00563, D00564, D00565, D00566, D00567, D00568, D00569, D00570, D00571, D00572, D00573, D00574, D00575, D00576, D00577, D00579, D00580, D00581, D00582, D00625, D00627, D00628, D00632, D00633, D00636, D00638, D00639, D00640, D00649, D00652, D00653, D00655, D00665, D00666, D00668, D00108, D00123, D00134, D00139, D00168, D00173, D00176, D00178, D00182, D00185, D00186, D00187, D00189, D00192, D00193, D00194, D00195, D00198, D00199, D00200, D00203, D00209, D00214, D00220, D00224, D00226, D00227, D00228, D00230, D00231, D00232, D00233, D00236, D00242, D00243, D00244, D00246, D00249, D00252, D00254, D00258, D00282, D00291, D00292, D00295, D00296, D00297, D00299, D00300, D00302, D00303, D00304, D00305, D00306, D00307, D00310, D00312, D00314, D00316, D00317, D00318, D00319, D00327, D00330, D00335, D00336, D00337, D00339, D00340, D00343, D00344, D00346, D00349, D00350, D00351, D00352, D00354, D00355, D00356, D00359, D00361, D00362, D00364, D00366, D00367, D00372, D00374, D00375, D00388, D00391, D00392, D00393, D00395, D00396, D00397, D00398, D00399, D00402, D00403, D00404, D00405, D00406, D00411, D00413, D00418, D00420, D00421, D00422, D00423, D00426, D00451, D00180, D00379, D00387, D00430, D00433, D00444, D00454, D00464, D00470, D00476, D00497, D00509, D00513, D00522, D00526, D00540, D00544, D00545, D00547, D00549, D00553, D00555, D00556, D00557, D00559, D00585, D00586, D00103, D00155, D00166, D00250, D00251, D00255, D00325, D00331, D00595, D00584, D00280, D00342, D00369, D00148, D00213, D00301, D00428, D00601, D00602, D00603, D00604, D00324, D00151, D00471, D00519, D00593, D00466, D00494, D00659, D00432, D00473, D00321, D00591, D00599, D00153, D00217, D00222, D00248, D00437, D00514, D00322, D00449, D00474, D00475, D00478, D00504, D00507, D00508, D00521, D00528, D00529, D00533, D00534, D00583, D00634, D00635, D00641, D00644, D00645, D00663, D00126, D00128, D00240, D00272, D00277, D00279, D00332, D00341, D00407, D00419, D00486, D00424, D00499, D00288, D00308, D00394, D00483, D00143, D00117, D00138, D00150, D00165, D00167, D00183, D00218, D00245, D00253, D00259, D00261, D00264, D00315, D00328, D00378, D00383, D00385, D00431, D00462, D00613, D00618, D00121, D00141, D00154, D00170, D00171, D00190, D00234, D00256, D00267, D00311, D00313, D00461, D00145, D00146, D00196, D00201, D00205, D00206, D00207, D00257, D00263, D00266, D00268, D00410, D00438, D00439, D00458, D00479, D00488, D00489, D00496, D00511, D00518, D00520, D00527, D00538, D00594, D00596, D00598, D00600, D00605, D00621, D00660, D00661, D00179, D00202, D00204, D00208, D00215, D00219, D00221, D00237, D00260, D00265, D00271, D00275, D00276, D00281, D00285, D00286, D00287, D00353, D00358, D00360, D00365, D00429, D00309, D00334, D00368, D00477, D00482, D00149, D00152, D00289, D00290, D00323, D00401, D00211, D00144, D00181, D00191, D00269, D00472, D00588, D00589, D00161, D00162, D00164, D00229, D00329, D00370, D00371, D00390, D00427, D00160, D00212, D00283, D00320, D00122, D00137, D00156, D00377, D00409, D00434, D00446, D00447, D00450, D00452, D00453, D00463, D00492, D00506, D00510, D00515, D00524, D00530, D00535, D00578, D00587, D00590, D00592, D00597, D00606, D00607, D00608, D00609, D00610, D00611, D00612, D00614, D00615, D00616, D00617, D00619, D00620, D00622, D00623, D00624, D00626, D00629, D00630, D00631, D00642, D00643, D00647, D00650, D00651, D00654, D00656, D00658, D00662, D00664, D00667, D00669, D00670, D00672, D00101, D00105, D00107, D00113, D00125, D00127, D00131, D00132, D00135, D00136, D00158, D00163, D00175, D00188, D00278, D00294.D00333, D00357, D00373, D00376, D00381, D00382, D00384, D00386, D00389, D00400, D00408, D00412, D00414, D00416, D00417, D00436, D00440, D00441, D00442, D00443, D00498, D00500, D00501.  Version 6.2.0 was distributed 3/24/07 and version 6.2.1: 4/10/07
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • 제조사 주소
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA