Events

Spacelabs Medical Vital Signs Monitor, Model 91220 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Incorporated 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
    55319
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3185-2011
  • 사례 시작날짜
    2010-04-14
  • 사례 출판 날짜
    2011-09-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90548
  • 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
    Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MHZ
  • 원인
    There have been reports that the spacelabs medical vital signs monitor, model 91220, will not power up with ac power and will no longer charge the batteries.
  • 조치
    SpaceLabs Healthcare sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 15, 2010, to all affected customers. International consignees were notified by e-mail on April 22, 2010, with the customer notification letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use the device until their monitors can be upgraded. Customers were asked to brief their staff about the possibility of the monitor failure to help prevent an adverse event from happening.

Device

Spacelabs Medical Vital Signs Monitor, Model 91220
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS: 1220M000275, 1220M000538, 1220M000552, 1220M000781, 1220M000902, 1220M000908, 1220M000910, 1220M000915, 1220M000917, 1220M000918, 1220M000919, 1220M000923, 1220M000925, 1220M000927, 1220M000928, 1220M000929, 1220M000930, 1220M000931, 1220M000932, 1220M000934, 1220M000935, 1220M000937, 1220M000938, 1220M000940, 1220M000941, 1220M000943, 1220M000944, 1220M000945, 1220M000947, 1220M000949, 1220M000950, 1220M000952, 1220M000953, 1220M000954, 1220M000955, 1220M000956, 1220M000957, 1220M000958, 1220M000959, 1220M000960, 1220M000962, 1220M000963, 1220M000964, 1220M000966, 1220M000968, 1220M000971, 1220M000972, 1220M000973, 1220M000974, 1220M000975, 1220M000977, 1220M000979, 1220M000980, 1220M000981, 1220M000982, 1220M000984, 1220M000985, 1220M000995, 1220M000996, 1220M000997, 1220M000999, 1220M001000, 1220M001001, 1220M001002, 1220M001003, 1220M001004, 1220M001005, 1220M001006, 1220M001007, 1220M001008, 1220M001009, 1220M001010, 1220M001013, 1220M001014, 1220M001015, 1220M001016, 1220M001017, 1220M001018, 1220M001020, 1220M001022, 1220M001023, 1220M001024, 1220M001025, 1220M001026, 1220M001028, 1220M001050, 1220M001051, 1220M001055, 1220M001056, 1220M001057, 1220M001059, 1220M001060, 1220M001061, 1220M001063, 1220M001064, 1220M001065, 1220M001066, 1220M001068, 1220M001069, 1220M001070, 1220M001071, 1220M001072, 1220M001075, 1220M001076, 1220M001078, 1220M001079, 1220M001080, 1220M001081, 1220M001083, 1220M001084, 1220M001085, 1220M001087, 1220M001088, 1220M001090, 1220M001091, 1220M001092, 1220M001093, 1220M001096, 1220M001099, 1220M001100, 1220M001101, 1220M001102, 1220M001103, 1220M001104, 1220M001106, 1220M001127, 1220M001128, 1220M001129, 1220M001130, 1220M001131, 1220M001132, 1220M001133, 1220M001134, 1220M001135, 1220M001136, 1220M001137, 1220M001138, 1220M001141, 1220M001142, 1220M001143, 1220M001145, 1220M001147, 1220M001148, 1220M001149, 1220M001151, 1220M001152, 1220M001154, 1220M001155, 1220M001156, 1220M001158, 1220M001162, 1220M001163, 1220M001164, 1220M001165, 1220M001166, 1220M001169, 1220M001171, 1220M001172, 1220M001173, 1220M001183, 1220M001184, 1220M001185, 1220M001186, 1220M001187, 1220M001188, 1220M001189, 1220M001190, 1220M001191, 1220M001192, 1220M001193, 1220M001194, 1220M001195, 1220M001196, 1220M001197, 1220M001198, 1220M001199, 1220M001200, 1220M001201, 1220M001202, 1220M001204, 1220M001205, 1220M001206, 1220M001207, 1220M001208, 1220M001209, 1220M001210, 1220M001211, 1220M001212, 1220M001213, 1220M001215, 1220M001216, 1220M001217, 1220M001218, 1220M001220, 1220M001221, 1220M001222, 1220M001223, 1220M001224, 1220M001225, 1220M001226, 1220M001227, 1220M001229, 1220M001232, 1220M001233, 1220M001234, 1220M001235, 1220M001236, 1220M001237, 1220M001238, 1220M001239, 1220M001240, 1220M001241, 1220M001242, 1220M001243, 1220M001244, 1220M001245, 1220M001246, 1220M001247, 1220M001248, 1220M001249, 1220M001250, 1220M001251, 1220M001252, 1220M001253, 1220M001254, 1220M001255, 1220M001256, 1220M001257, 1220M001258, 1220M001260, 1220M001261, 1220M001262, 1220M001263, 1220M001264, 1220M001265, 1220M001266, 1220M001267, 1220M001268, 1220M001269, 1220M001270, 1220M001271, 1220M001272, 1220M001273, 1220M001274, 1220M001275, 1220M001276, 1220M001277, 1220M001278, 1220M001279, 1220M001280, 1220M001285, 1220M001290, 1220M001297, 1220M001298, 1220M001299, 1220M001302, 1220M001303, 1220M001305, 1220M001306, 1220M001307, 1220M001308, 1220M001309, 1220M001310, 1220M001312, 1220M001313, 1220M001314, 1220M001315, 1220M001317, 1220M001318, 1220M001319, 1220M001320, 1220M001321, 1220M001322, 1220M001323, 1220M001324, 1220M001325, 1220M001326, 1220M001327, 1220M001328, 1220M001329, 1220M001330, 1220M001331, 1220M001332, 1220M001333, 1220M001334, 1220M001335, 1220M001336, 1220M001338, 1220M001339, 1220M001340, 1220M001341, 1220M001342, 1220M001343, 1220M001344, 1220M001345, 1220M001346, 1220M001347, 1220M001348, 1220M001349, 1220M001350, 1220M001351, 1220M001352, 1220M001353, 1220M001354, 1220M001355, 1220M001356, 1220M001357, 1220M001358, 1220M001359, 1220M001360, 1220M001361, 1220M001362, 1220M001363, 1220M001364, 1220M001365, 1220M001366, 1220M001368, 1220M001369, 1220M001370, 1220M001371, 1220M001372, 1220M001373, 1220M001374, 1220M001375, 1220M001376, 1220M001377, 1220M001378, 1220M001379, 1220M001380, 1220M001381, 1220M001382, 1220M001384, 1220M001385, 1220M001386, 1220M001387, 1220M001388, 1220M001389, 1220M001390, 1220M001391, 1220M001392, 1220M001395, 1220M001396, 1220M001397, 1220M001398, 1220M001400, 1220M001401, 1220M001402, 1220M001403, 1220M001404, 1220M001405, 1220M001406, 1220M001407, 1220M001408, 1220M001409, 1220M001410, 1220M001411, 1220M001412, 1220M001413, 1220M001414, 1220M001415, 1220M001416, 1220M001417, 1220M001418, 1220M001419, 1220M001420, 1220M001421, 1220M001422, 1220M001423, 1220M001424, 1220M001425, 1220M001426, 1220M001427, 1220M001428, 1220M001429, 1220M001430, 1220M001431, 1220M001432, 1220M001433, 1220M001434, 1220M001435, 1220M001436, 1220M001437, 1220M001438, 1220M001439, 1220M001440, 1220M001441, 1220M001442, 1220M001443, 1220M001444, 1220M001445, 1220M001446, 1220M001447, 1220M001448, 1220M001449, 1220M001450, 1220M001451, 1220M001452, 1220M001453, 1220M001454, 1220M001455, 1220M001456, 1220M001457, 1220M001458, 1220M001459, 1220M001460, 1220M001461, 1220M001462, 1220M001463, 1220M001464, 1220M001465, 1220M001466, 1220M001467, 1220M001468, 1220M001469, 1220M001470, 1220M001471, 1220M001472, 1220M001473, 1220M001474, 1220M001475, 1220M001476, 1220M001477, 1220M001478, 1220M001479, 1220M001480, 1220M001481, 1220M001482, 1220M001483, 1220M001484, 1220M001485, 1220M001486, 1220M001487, 1220M001488, 1220M001489, 1220M001490, 1220M001491, 1220M001492, 1220M001493, 1220M001494, 1220M001495, 1220M001496, 1220M001497, 1220M001499, 1220M001500, 1220M001501, 1220M001502, 1220M001503, 1220M001504, 1220M001505, 1220M001506, 1220M001507, 1220M001508, 1220M001509, 1220M001510, 1220M001511, 1220M001512, 1220M001514, 1220M001515, 1220M001516, 1220M001517, 1220M001518, 1220M001519, 1220M001520, 1220M001521, 1220M001522, 1220M001523, 1220M001524, 1220M001525, 1220M001526, 1220M001527, 1220M001528, 1220M001529, 1220M001530, 1220M001531, 1220M001532, 1220M001533, 1220M001534, 1220M001535, 1220M001536, 1220M001537, 1220M001538, 1220M001539, 1220M001540, 1220M001543, 1220M001544, 1220M001545, 1220M001546, 1220M001547, 1220M001548, 1220M001549, 1220M001550, 1220M001551, 1220M001552, 1220M001553, 1220M001554, 1220M001555, 1220M001556, 1220M001557, 1220M001558, 1220M001559, 1220M001560, 1220M001561, 1220M001562, 1220M001563, 1220M001564, 1220M001565, 1220M001566, 1220M001567, 1220M001568, 1220M001569, 1220M001570, 1220M001571, 1220M001572, 1220M001573, 1220M001574, 1220M001575, 1220M001576, 1220M001578, 1220M001579, 1220M001580, 1220M001581, 1220M001582, 1220M001583, 1220M001584, 1220M001585, 1220M001586, 1220M001587, 1220M001588, 1220M001589, 1220M001590, 1220M001591, 1220M001592, 1220M001593, 1220M001594, 1220M001595, 1220M001596, 1220M001597, 1220M001598, 1220M001599, 1220M001600, 1220M001601, 1220M001602, 1220M001603, 1220M001604, 1220M001605, 1220M001606, 1220M001607, 1220M001608, 1220M001609, 1220M001610, 1220M001611, 1220M001612, 1220M001613, 1220M001614, 1220M001615, 1220M001616, 1220M001617, 1220M001618, 1220M001619, 1220M001620, 1220M001621, 1220M001622, 1220M001623, 1220M001624, 1220M001625, 1220M001626, 1220M001627, 1220M001628, 1220M001629, 1220M001630, 1220M001631, 1220M001632, 1220M001633, 1220M001634, 1220M001635, 1220M001636, 1220M001637, 1220M001638, 1220M001639, 1220M001640, 1220M001641, 1220M001642, 1220M001643, 1220M001644, 1220M001645, 1220M001646, 1220M001647, 1220M001648, 1220M001649, 1220M001650, 1220M001651, 1220M001652, 1220M001653, 1220M001654, 1220M001655, 1220M001656, 1220M001658, 1220M001659, 1220M001660, 1220M001719, 1220M001720, 1220M001721, 1220M001722, 1220M001723, 1220M001724, 1220M001725, 1220M001726, 1220M001727, 1220M001728, 1220M001729, 1220M001730, 1220M001731, 1220M001732, and 1220M001742.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of UNITED ARAB EMIRATES, ARGENTINA, AUSTRALIA, BELGIUM, BAHRAIN, BRAZIL, CANADA, CHINA, COLOMBIA, GERMANY, ECUADOR, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, JORDAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, MALAYSIA, OMAN, POLAND, PUERTO RICO, PARAGUAY, ROMANIA, SAUDI ARABIA, SINGAPORE, SYRIAN ARAB REPUBLIC, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and URUGUAY.
  • 제품 설명
    The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. || The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • 제조사 주소
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA