Device Recall Spacelabs Medical Flat Panel Display 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Llc 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
    57370
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0620-2011
  • 사례 시작날짜
    2009-03-20
  • 사례 출판 날짜
    2010-12-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-06-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Display, cathode-ray tube, medical - Product Code DXJ
  • 원인
    The power supply of the spacelabs medical flat panel display may fail, causing the display to go blank.
  • 조치
    Spacelabs Healthcare sent an URGENT: MEDICAL DEVICE RECALL Spacelabs Medical Flat Panel Power Supply PNs: 010-1619-00 & 010-1655-00 letter dated March 20, 2009 to US consignees. On March 27, 2009, Spacelabs sent the same recall letter with translation option to their international consignees.The letter stated the firm would be sending a replacement power supply. While waiting for the replacement of the power supply, Spacelabs Medical recommended their consignees brief the staff on the possibility of the display going blank to help prevent any adverse event from happening. The consignees were advised to dispose the old power supply per their premise protocol or local regulations. The consignees from US can contact Spacelabs Medical at 1-800-522-7025, #2 for Technical Support , and consignees outside the United States can call 1-425-657-7200 x5089 for any questions about the recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    Date Codes (WK numbers) identified on the affected power supplies:  0647, 0703, 0706, 0707, 0709, 0712, 0724, 0727, 0728 or 0732.  Lot/Serial Numbers on the systems for US Consignees:  ELZ-0011442, ELZ-0012143, ELZ-0013307, ELZ-0013557, ELZ-0014567,  ELZ-0014570, ELZ-0014574, ELZ-0014577, ELZ-0014580, ELZ-0014583,  ELZ-0014585, ELZ-0014586, ELZ-0014587, ELZ-0014590, ELZ-0014591,  ELZ-0014592, ELZ-0014593, ELZ-0014594, ELZ-0014595, ELZ-0014596,  ELZ-0014597, ELZ-0014598, ELZ-0014599, ELZ-0014600, ELZ-0014601,  ELZ-0014603, ELZ-0014604, ELZ-0014605, ELZ-0014606, ELZ-0014607,  ELZ-0014608, ELZ-0014609, ELZ-0014610, ELZ-0014611, ELZ-0014612,  ELZ-0014613, ELZ-0014614, ELZ-0014615, ELZ-0014616, ELZ-0014617,  ELZ-0014618, ELZ-0014619, ELZ-0014620, ELZ-0014621, ELZ-0014622,  ELZ-0014623, ELZ-0014625, ELZ-0014626, ELZ-0014629, ELZ-0014630,  ELZ-0014631, ELZ-0014632, ELZ-0014633, ELZ-0014634, ELZ-0014635,  ELZ-0014636, ELZ-0014637, ELZ-0014638, ELZ-0014639, ELZ-0014640,  ELZ-0014641, ELZ-0014645, ELZ-0014648, ELZ-0014656, ELZ-0014657,  ELZ-0014658, ELZ-0014718, ELZ-0014719, ELZ-0014720, ELZ-0014723,  ELZ-0014724, ELZ-0014726, ELZ-0014727, ELZ-0014729, ELZ-0014731,  ELZ-0014733, ELZ-0014736, ELZ-0014737, ELZ-0014738, ELZ-0014740,  ELZ-0014742, ELZ-0014744, ELZ-0014745, ELZ-0014750, ELZ-0014752,  ELZ-0014754, ELZ-0014755, ELZ-0014756, ELZ-0014758, ELZ-0014759,  ELZ-0014760, ELZ-0014762, ELZ-0014764, ELZ-0014765, ELZ-0014766,  ELZ-0014767, ELZ-0014768, ELZ-0014770, ELZ-0014771, ELZ-0014772, ELZ-0014773, ELZ-0014774, ELZ-0014775, ELZ-0014776, ELZ-0014780, ELZ-0014781, ELZ-0014782, ELZ-0014783, ELZ-0014786, ELZ-0014787, ELZ-0014788, ELZ-0014790, ELZ-0014791, ELZ-0014795, ELZ-0014800, ELZ-0014805, ELZ-0014806, ELZ-0014810, ELZ-0014816, ELZ-0014817, ELZ-0014819, ELZ-0014820, ELZ-0014823, ELZ-0014824, ELZ-0014827, ELZ-0014828, ELZ-0014833, ELZ-0014834, ELZ-0014836, ELZ-0014837, ELZ-0014839, ELZ-0014842, ELZ-0014846, ELZ-0014852, ELZ-0014853, ELZ-0014854, ELZ-0014857, ELZ-0014858, ELZ-0014859, ELZ-0014861, ELZ-0014863, ELZ-0014864, ELZ-0014865, ELZ-0014866, ELZ-0014867, ELZ-0014868, ELZ-0014869, ELZ-0014872, ELZ-0014873, ELZ-0014874, ELZ-0014875, ELZ-0014876, ELZ-0014877, ELZ-0014878, ELZ-0014879, ELZ-0014880, ELZ-0014881, ELZ-0014882, ELZ-0014883, ELZ-0014885, ELZ-0014886, ELZ-0014890, ELZ-0014891, ELZ-0014892, ELZ-0014893, ELZ-0014894, ELZ-0014895, ELZ-0014896, ELZ-0014900, ELZ-0014902, ELZ-0014905, ELZ-0014906, ELZ-0014910, ELZ-0014913, ELZ-0014914, ELZ-0014915, ELZ-0014916, ELZ-0014917, ELZ-0014920, ELZ-0014922, ELZ-0014925, ELZ-0014926, ELZ-0014927, ELZ-0014930, ELZ-0014931, ELZ-0014933, ELZ-0014934, ELZ-0014935, ELZ-0014936, ELZ-0014937, ELZ-0014938, ELZ-0014940, ELZ-0014941, ELZ-0014942, ELZ-0014943, ELZ-0014944, ELZ-0014945, ELZ-0014947, ELZ-0014949, ELZ-0014950, ELZ-0014951, ELZ-0014953, ELZ-0014954, ELZ-0014955, ELZ-0014956, ELZ-0014957, ELZ-0014958, ELZ-0014959, ELZ-0014960, ELZ-0014961, ELZ-0014964, ELZ-0014965, ELZ-0014968, ELZ-0014969, ELZ-0014972, ELZ-0014973, ELZ-0014974, ELZ-0014975, ELZ-0014976, ELZ-0014977, ELZ-0014979, ELZ-0014981, ELZ-0014982, ELZ-0014983, ELZ-0014985, ELZ-0014986, ELZ-0014987, ELZ-0014989, ELZ-0014992, ELZ-0014994, ELZ-0014995, ELZ-0014996, ELZ-0014999, ELZ-0015000, ELZ-0015001, ELZ-0015002, ELZ-0015005, ELZ-0015006, ELZ-0015007, ELZ-0015008, ELZ-0015009, ELZ-0015010, ELZ-0015011, ELZ-0015012, ELZ-0015013, ELZ-0015014, ELZ-0015015, ELZ-0015016, ELZ-0015017, ELZ-0015018, ELZ-0015019, ELZ-0015020, ELZ-0015021, ELZ-0015022, ELZ-0015023, ELZ-0015024, ELZ-0015025, ELZ-0015026, ELZ-0015027, ELZ-0015028, ELZ-0015029, ELZ-0015030, ELZ-0015031, ELZ-0015032, ELZ-0015033, ELZ-0015034, ELZ-0015035, ELZ-0015036, ELZ-0015037, ELZ-0015038, ELZ-0015039, ELZ-0015040, ELZ-0015042, ELZ-0015043, ELZ-0015044, ELZ-0015045, ELZ-0015046, ELZ-0015047, ELZ-0015048, ELZ-0015050, ELZ-0015051, ELZ-0015052, ELZ-0015053, ELZ-0015054, ELZ-0015055, ELZ-0015056, ELZ-0015057, ELZ-0015058, ELZ-0015059, ELZ-0015060, ELZ-0015061, ELZ-0015063, ELZ-0015064, ELZ-0015065, ELZ-0015066, ELZ-0015067, ELZ-0015068, ELZ-0015069, ELZ-0015070, ELZ-0015071, ELZ-0015073, ELZ-0015074, ELZ-0015075, ELZ-0015076, ELZ-0015077, ELZ-0015078, ELZ-0015080, ELZ-0015081, ELZ-0015082, ELZ-0015083, ELZ-0015084, ELZ-0015085, ELZ-0015087, ELZ-0015088, ELZ-0015089, ELZ-0015090, ELZ-0015091, ELZ-0015093, ELZ-0015094, ELZ-0015095, ELZ-0015096, ELZ-0015097, ELZ-0015098, ELZ-0015099, ELZ-0015100, ELZ-0015101, ELZ-0015102, ELZ-0015103, ELZ-0015104, ELZ-0015105, ELZ-0015107, ELZ-0015113, ELZ-0015114, ELZ-0015118, ELZ-0015119, ELZ-0015120, ELZ-0015121, ELZ-0015122, ELZ-0015123, ELZ-0015125, ELZ-0015126, ELZ-0015128, ELZ-0015129, ELZ-0015130, ELZ-0015132, ELZ-0015133, ELZ-0015134, ELZ-0015135, ELZ-0015136, ELZ-0015138, ELZ-0015139, ELZ-0015140, ELZ-0015144, ELZ-0015145, ELZ-0015150, ELZ-0015154, ELZ-0015155, ELZ-0015157, ELZ-0015158, ELZ-0015159, ELZ-0015161, ELZ-0015164, ELZ-0015165, ELZ-0015166, ELZ-0015167, ELZ-0015168, ELZ-0015169, ELZ-0015173, ELZ-0015174, ELZ-0015179, ELZ-0015181, ELZ-0015184, ELZ-0015187, ELZ-0015189, ELZ-0015194, ELZ-0015197, ELZ-0015199, ELZ-0015200, ELZ-0015201, ELZ-0015203, ELZ-0015204, ELZ-0015205, ELZ-0015206, ELZ-0015207, ELZ-0015208, ELZ-0015209, ELZ-0015210, ELZ-0015212, ELZ-0015213, ELZ-0015214, ELZ-0015215, ELZ-0015216, ELZ-0015217, ELZ-0015218, ELZ-0015219, ELZ-0015220, ELZ-0015221, ELZ-0015222, ELZ-0015223, ELZ-0015224, ELZ-0015225, ELZ-0015226, ELZ-0015227, ELZ-0015228, ELZ-0015229, ELZ-0015230, ELZ-0015231, ELZ-0015232, ELZ-0015233, ELZ-0015234, ELZ-0015235, ELZ-0015236, ELZ-0015237, ELZ-0015238, ELZ-0015239, ELZ-0015240, ELZ-0015241, ELZ-0015242, ELZ-0015243, ELZ-0015244, ELZ-0015245, ELZ-0015246, ELZ-0015247, ELZ-0015248, ELZ-0015249, ELZ-0015250, ELZ-0015251, ELZ-0015252, ELZ-0015253, ELZ-0015255, ELZ-0015256, ELZ-0015257, ELZ-0015262, ELZ-0015264, ELZ-0015265, ELZ-0015266, ELZ-0015267, ELZ-0015268, ELZ-0015271, ELZ-0015273, ELZ-0015274, ELZ-0015276, ELZ-0015277, ELZ-0015279, ELZ-0015280, ELZ-0015281, ELZ-0015282, ELZ-0015284, ELZ-0015285, ELZ-0015286, ELZ-0015288, ELZ-0015291, ELZ-0015292, ELZ-0015293, ELZ-0015294, ELZ-0015295, ELZ-0015296, ELZ-0015297, ELZ-0015298, ELZ-0015299, ELZ-0015300, ELZ-0015301, ELZ-0015302, ELZ-0015303, ELZ-0015304, ELZ-0015305, ELZ-0015306, ELZ-0015307, ELZ-0015308, ELZ-0015309, ELZ-0015310, ELZ-0015311, ELZ-0015312, ELZ-0015315, ELZ-0015316, ELZ-0015317, ELZ-0015318, ELZ-0015319, ELZ-0015320, ELZ-0015321, ELZ-0015322, ELZ-0015323, ELZ-0015326, ELZ-0015327, ELZ-0015328, ELZ-0015330, ELZ-0015331, ELZ-0015332, ELZ-0015333, ELZ-0015334, ELZ-0015335, ELZ-0015336, ELZ-0015337, ELZ-0015338, ELZ-0015339, ELZ-0015340, ELZ-0015341, ELZ-0015342, ELZ-0015343, ELZ-0015344, ELZ-0015345, ELZ-0015346, ELZ-0015347, ELZ-0015348, ELZ-0015349, ELZ-0015350, ELZ-0015351, ELZ-0015352, ELZ-0015353, ELZ-0015354, ELZ-0015355, ELZ-0015357, ELZ-0015358, ELZ-0015359, ELZ-0015360, ELZ-0015361, ELZ-0015362, ELZ-0015363, ELZ-0015364, ELZ-0015365, ELZ-0015366, ELZ-0015367, ELZ-0015368, ELZ-0015369, ELZ-0015370, ELZ-0015371, ELZ-0015372, ELZ-0015373, ELZ-0015374, ELZ-0015375, ELZ-0015376, ELZ-0015377, ELZ-0015378, ELZ-0015379, ELZ-0015380, ELZ-0015381, ELZ-0015382, ELZ-0015383, ELZ-0015384, ELZ-0015385, ELZ-0015386, ELZ-0015387, ELZ-0015388, ELZ-0015389, ELZ-0015390, ELZ-0015391, ELZ-0015392, ELZ-0015393, ELZ-0015394, ELZ-0015395, ELZ-0015396, ELZ-0015397, ELZ-0015398, ELZ-0015399, ELZ-0015400, ELZ-0015401, ELZ-0015402, ELZ-0015403, ELZ-0015404, ELZ-0015405, ELZ-0015406, ELZ-0015407, ELZ-0015408, ELZ-0015409, ELZ-0015410, ELZ-0015411, ELZ-0015412, ELZ-0015413, ELZ-0015414, ELZ-0015415, ELZ-0015418, ELZ-0015419, ELZ-0015420, ELZ-0015422, ELZ-0015426, ELZ-0015427, ELZ-0015429, ELZ-0015430, ELZ-0015432, ELZ-0015434, ELZ-0015436, ELZ-0015437, ELZ-0015438, ELZ-0015439, ELZ-0015441, ELZ-0015442, ELZ-0015443, ELZ-0015444, ELZ-0015445, ELZ-0015446, ELZ-0015447, ELZ-0015448, ELZ-0015449, ELZ-0015450, ELZ-0015451, ELZ-0015452, ELZ-0015453, ELZ-0015454, ELZ-0015455, ELZ-0015456, ELZ-0015457, ELZ-0015458, ELZ-0015459, ELZ-0015460, ELZ-0015461, ELZ-0015462, ELZ-0015463, ELZ-0015464, ELZ-0015465, ELZ-0015466, ELZ-0015467, ELZ-0015468, ELZ-0015469, ELZ-0015470, ELZ-0015471, ELZ-0015472, ELZ-0015473, ELZ-0015474, ELZ-0015475, ELZ-0015476, ELZ-0015479, ELZ-0015480, ELZ-0015482, ELZ-0015485, ELZ-0015486, ELZ-0015488, ELZ-0015489, ELZ-0015490, ELZ-0015495, ELZ-0015501, ELZ-0015503, ELZ-0015506, ELZ-0015509, ELZ-0015510, ELZ-0015511, ELZ-0015523, ELZ-0015526, ELZ-0015529, ELZ-0015536, ELZ-0015537, ELZ-0015538, ELZ-0015539, ELZ-0015540, ELZ-0015541, ELZ-0015542, ELZ-0015543, ELZ-0015544, ELZ-0015545, ELZ-0015546, ELZ-0015547, ELZ-0015549, ELZ-0015550, ELZ-0015551, ELZ-0015552, ELZ-0015553, ELZ-0015554, ELZ-0015555, ELZ-0015556, ELZ-0015558, ELZ-0015559, ELZ-0015560, ELZ-0015561, ELZ-0015562, ELZ-0015564, ELZ-0015566, ELZ-0015567, ELZ-0015568, ELZ-0015570, ELZ-0015571, ELZ-0015572, ELZ-0015573, ELZ-0015574, ELZ-0015575, ELZ-0015576, ELZ-0015577, ELZ-0015578, ELZ-0015579, ELZ-0015580, ELZ-0015581, ELZ-0015582, ELZ-0015583, ELZ-0015584, ELZ-0015585, ELZ-0015586, ELZ-0015587, ELZ-0015588, ELZ-0015589, ELZ-0015590, ELZ-0015591, ELZ-0015592, ELZ-0015593, ELZ-0015594, ELZ-0015597, ELZ-0015598, ELZ-0015599, ELZ-0015600, ELZ-0015601, ELZ-0015602, ELZ-0015603, ELZ-0015604, ELZ-0015605, ELZ-0015606, ELZ-0015608, ELZ-0015609, ELZ-0015611, ELZ-0015612, ELZ-0015613, ELZ-0015614, ELZ-0015615, ELZ-0015616, ELZ-0015617, ELZ-0015618, ELZ-0015619, ELZ-0015620, ELZ-0015621, ELZ-0015622, ELZ-0015624, ELZ-0015625, ELZ-0015626, ELZ-0015646, ELZ-0015647, ELZ-0015648, ELZ-0015649, ELZ-0015650, ELZ-0015651, ELZ-0015654, ELZ-0015655, ELZ-0015656, ELZ-0015657, ELZ-0015658, ELZ-0015659, ELZ-0015660, ELZ-0015661, ELZ-0015662, ELZ-0015664, ELZ-0015665, ELZ-0015666, ELZ-0015667, ELZ-0015668, ELZ-0015669, ELZ-0015670, ELZ-0015671, ELZ-0015672, ELZ-0015673, ELZ-0015674, ELZ-0015675, ELZ-0015676, ELZ-0015677, ELZ-0015678, ELZ-0015679, ELZ-0015680, ELZ-0015681, ELZ-0015682, ELZ-0015683, ELZ-0015684, ELZ-0015685, ELZ-0015686, ELZ-0015687, ELZ-0015688, ELZ-0015689, ELZ-0015690, ELZ-0015691, ELZ-0015692, ELZ-0015693, ELZ-0015694, ELZ-0015696, ELZ-0015697, ELZ-0015698, ELZ-0015699, ELZ-0015700, ELZ-0015701, ELZ-0015702, ELZ-0015703, ELZ-0015704, ELZ-0015705, ELZ-0015706, ELZ-0015707, ELZ-0015708, ELZ-0015709, ELZ-0015710, ELZ-0015711, ELZ-0015712, ELZ-0015713, ELZ-0015714, ELZ-0015715, ELZ-0015716, ELZ-0015717, ELZ-0015718, ELZ-0015719, ELZ-0015720, ELZ-0015722, ELZ-0015723, ELZ-0015724, ELZ-0015725, ELZ-0015726, ELZ-0015727, ELZ-0015728, ELZ-0015731, ELZ-0015732, ELZ-0015736, ELZ-0015737, ELZ-0015738, ELZ-0015739, ELZ-0015740, ELZ-0015741, ELZ-0015742, ELZ-0015744, ELZ-0015745, ELZ-0015746, ELZ-0015747, ELZ-0015748, ELZ-0015749, ELZ-0015750, ELZ-0015751, ELZ-0015752, ELZ-0015753, ELZ-0015754, ELZ-0015755, ELZ-0015756, ELZ-0015758, ELZ-0015760, ELZ-0015762, ELZ-0015763, ELZ-0015764, ELZ-0015765, ELZ-0015770, ELZ-0015771, ELZ-0015772, ELZ-0015773, ELZ-0015775, ELZ-0015776, ELZ-0015777, ELZ-0015778, ELZ-0015781, ELZ-0015782, ELZ-0015783, ELZ-0015784, ELZ-0015785, ELZ-0015786, ELZ-0015787, ELZ-0015788, ELZ-0015789, ELZ-0015790, ELZ-0015791, ELZ-0015792, ELZ-0015793, ELZ-0015794, ELZ-0015795, ELZ-0015798, ELZ-0015799, ELZ-0015800, ELZ-0015801, ELZ-0015802, ELZ-0015803, ELZ-0015804, ELZ-0015805, ELZ-0015806, ELZ-0015807, ELZ-0015808, ELZ-0015809, ELZ-0015810, ELZ-0015811, ELZ-0015812, ELZ-0015813, ELZ-0015814, ELZ-0015815, ELZ-0015816, ELZ-0015817, ELZ-0015818, ELZ-0015819, ELZ-0015820, ELZ-0015821, ELZ-0015822, ELZ-0015823, ELZ-0015824, ELZ-0015825, ELZ-0015826, ELZ-0015827, ELZ-0015828, ELZ-0015829, ELZ-0015830, ELZ-0015831, ELZ-0015832, ELZ-0015833, ELZ-0015834, ELZ-0015835, ELZ-0015836, ELZ-0015837, ELZ-0015838, ELZ-0015839, ELZ-0015840, ELZ-0015841, ELZ-0015842, ELZ-0015843, ELZ-0015844, ELZ-0015845, ELZ-0015846, ELZ-0015847, ELZ-0015848, ELZ-0015849, ELZ-0015850, ELZ-0015851, ELZ-0015852, ELZ-0015853, ELZ-0015854, ELZ-0015855, ELZ-0015856, 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ELZ-77135973, ELZ-77135976, ELZ-77135977, ELZ-77135981, ELZ-77135982, ELZ-77135985, ELZ-77135987, ELZ-77135990, ELZ-77135990, ELZ-77135992, ELZ-77135996, ELZ-77166572, ELZ-77166573, ELZ-77166574, ELZ-77166575, ELZ-77166576, ELZ-77166577, ELZ-77166578, ELZ-77166579, ELZ-77166580, ELZ-77166582, ELZ-77166584, ELZ-77166585, ELZ-77385615, ELZ-77385616, ELZ-77385617, ELZ-77385618, ELZ-77385619, ELZ-77385620, ELZ-77385621, ELZ-77385622, ELZ-77385623, ELZ-77385624, ELZ-77385625, ELZ-77385626, ELZ-77385627, ELZ-77385628, ELZ-77385629, ELZ-77385630, ELZ-77385631, ELZ-77385632, ELZ-77385633, ELZ-77385634, ELZ-77385635, ELZ-77385636, ELZ-77385637, ELZ-77385638, ELZ-77385639, ELZ-77385640, ELZ-77385641, ELZ-77385642, ELZ-77385643, ELZ-77385644, ELZ-77385645, ELZ-77385646, ELZ-77385647, ELZ-77385648, ELZ-77385649, ELZ-77385650, ELZ-77385651, ELZ-77385652, ELZ-77385653, ELZ-77385654, ELZ-77385655, ELZ-77385656, ELZ-77385657, ELZ-77385658, ELZ-77385659, ELZ-77385660, ELZ-77385661, ELZ-77385662, 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ELZ-77385738, ELZ-77385739, ELZ-77385740, ELZ-77385741, ELZ-77385742, ELZ-77385743, ELZ-77385744, ELZ-77385745, ELZ-77385746, ELZ-77385747, ELZ-77385748, ELZ-77385749, ELZ-77385750, ELZ-77385751, ELZ-77385752, ELZ-77385753, ELZ-77385755, ELZ-77385756, ELZ-77385759, ELZ-77385760, ELZ-77385761, ELZ-77385762, ELZ-77385763, ELZ-77385764, ELZ-77385765, ELZ-77385766, ELZ-77385767, ELZ-77385768, ELZ-77385769, ELZ-77385770, ELZ-77385771, ELZ-77385772, ELZ-77385773, ELZ-77385774, ELZ-77385776, ELZ-77385777, ELZ-77385778, ELZ-77385779, ELZ-77385781, ELZ-77385783, ELZ-77385784, ELZ-77385785, ELZ-77385786, ELZ-77385787, ELZ-77385788, ELZ-77385789, ELZ-77385790, ELZ-77385791, ELZ-77385792, ELZ-77385793, ELZ-77385797, ELZ-77385820, ELZ-77385821, ELZ-77385822, ELZ-77385823, ELZ-77385824, ELZ-77385825, ELZ-77385826, ELZ-77385828, ELZ-77385829, ELZ-77385830, ELZ-77385831, ELZ-77385832, ELZ-77385833, ELZ-77385834, ELZ-77385835, ELZ-77385836, ELZ-77385837, ELZ-77385838, ELZ-77385839, ELZ-77385840, ELZ-77385843, ELZ-77385845, ELZ-77385846, ELZ-77385847, ELZ-77385851, ELZ-77385852, ELZ-77385853, ELZ-77385854, ELZ-77385857, ELZ-77385858, ELZ-77385860, ELZ-77385862, ELZ-77385864, ELZ-77385869, ELZ-77385871, ELZ-77385874, ELZ-77385875, ELZ-77385876, ELZ-77385879, ELZ-77385880, ELZ-77385881, ELZ-77385882, ELZ-77385885, ELZ-77385886, ELZ-77385887, ELZ-77385888, ELZ-77385889, ELZ-77385890, ELZ-77385893, ELZ-77385894, ELZ-77385895, ELZ-77385896, ELZ-77385897, ELZ-77385898, ELZ-77385899, ELZ-77385900, ELZ-77385902, ELZ-77385903, ELZ-77385904, ELZ-77385907, ELZ-77385908, ELZ-77385909, ELZ-77385910, ELZ-77385911, ELZ-77385912, ELZ-77385913, ELZ-77385914, ELZ-77385915, ELZ-77385916, ELZ-77385917, ELZ-77385918, ELZ-77385919, ELZ-77385920, ELZ-77385921, ELZ-77385922, ELZ-77385923, ELZ-77385924, ELZ-77385925, ELZ-77385926, ELZ-77385927, ELZ-77385928, ELZ-77385929, ELZ-77385930, ELZ-77385931, ELZ-77385932, ELZ-77385933, ELZ-77385934, ELZ-77385935, ELZ-77385936, ELZ-77385937, ELZ-77385938, ELZ-77385939, ELZ-77385940, ELZ-77385941, ELZ-77385943, ELZ-77385944, ELZ-77385946, ELZ-77385947, ELZ-77385948, ELZ-77385949, ELZ-77385950, ELZ-77385951, ELZ-77385952, ELZ-77385955, ELZ-77385956, ELZ-77385957, ELZ-77385959, ELZ-77385960, ELZ-77385961, ELZ-77385962, ELZ-77385963, ELZ-77385965, ELZ-77385966, ELZ-77385967, ELZ-77385968, ELZ-77385969, ELZ-77385971, ELZ-77385972, ELZ-77385973, ELZ-77385974, ELZ-77385975, ELZ-77385976, ELZ-77385978, ELZ-77385979, ELZ-77385980, ELZ-77385981, ELZ-77385982, ELZ-77385983, ELZ-77385984, ELZ-77385985, ELZ-77385986, ELZ-77385987, ELZ-77385988, ELZ-77385989, ELZ-77385990, ELZ-77385991, ELZ-77385992, ELZ-77385993, ELZ-77385994, ELZ-77385995, ELZ-77385996, ELZ-77385997, ELZ-77385998, ELZ-77385999, ELZ-77386000, ELZ-77386001, ELZ-77386002, ELZ-77386003, ELZ-77386004, ELZ-77386005, ELZ-77386006, ELZ-77386007, ELZ-77386008, ELZ-77386009, ELZ-77386010, ELZ-77386011, ELZ-77386012, ELZ-77386013, ELZ-77386014, ELZ-77386015, ELZ-77386016, ELZ-77386017, ELZ-77386018, ELZ-77386019, ELZ-77386020, ELZ-77386021, ELZ-77386022, ELZ-77386023, ELZ-77386024, ELZ-77386025, ELZ-77386026, ELZ-77386027, ELZ-77386028, ELZ-77386029, ELZ-77386030, ELZ-77386031, ELZ-77386032, ELZ-77386033, ELZ-77386034, and ELZ-77386035.  Lot/Serial Numbers on the systems for Foreign Consignees:  ELZ-0014568, ELZ-0014569, ELZ-0014571, ELZ-0014572, ELZ-0014573, ELZ-0014575, ELZ-0014576, ELZ-0014578, ELZ-0014579, ELZ-0014582, ELZ-0014584, ELZ-0014588, ELZ-0014589, ELZ-0014602, ELZ-0014624, ELZ-0014627, ELZ-0014628, ELZ-0014643, ELZ-0014644, ELZ-0014646, ELZ-0014649, ELZ-0014650, ELZ-0014651, ELZ-0014652, ELZ-0014655, ELZ-0014659, ELZ-0014660, ELZ-0014661, ELZ-0014721, ELZ-0014722, ELZ-0014725, ELZ-0014728, ELZ-0014730, ELZ-0014732, ELZ-0014734, ELZ-0014739, ELZ-0014741, ELZ-0014743, ELZ-0014746, ELZ-0014747, ELZ-0014748, ELZ-0014749, ELZ-0014751, ELZ-0014753, ELZ-0014757, ELZ-0014761, ELZ-0014763, ELZ-0014769, ELZ-0014777, ELZ-0014778, ELZ-0014779, ELZ-0014784, ELZ-0014789, ELZ-0014792, ELZ-0014794, ELZ-0014796, ELZ-0014797, ELZ-0014798, ELZ-0014799, ELZ-0014801, ELZ-0014802, ELZ-0014803, ELZ-0014804, ELZ-0014807, ELZ-0014808, ELZ-0014809, ELZ-0014811, ELZ-0014812, ELZ-0014813, ELZ-0014814, ELZ-0014815, ELZ-0014818, ELZ-0014821, ELZ-0014822, ELZ-0014825, ELZ-0014826, ELZ-0014829, ELZ-0014830, ELZ-0014831, ELZ-0014832, ELZ-0014835, ELZ-0014838, ELZ-0014840, ELZ-0014841, ELZ-0014843, ELZ-0014844, ELZ-0014845, ELZ-0014847, ELZ-0014848, ELZ-0014849, ELZ-0014851, ELZ-0014856, ELZ-0014862, ELZ-0014870, ELZ-0014884, ELZ-0014889, ELZ-0014897, ELZ-0014898, ELZ-0014899, ELZ-0014901, ELZ-0014903, ELZ-0014904, ELZ-0014907, ELZ-0014908, ELZ-0014909, ELZ-0014911, ELZ-0014912, ELZ-0014918, ELZ-0014919, ELZ-0014921, ELZ-0014923, ELZ-0014928, ELZ-0014939, ELZ-0014946, ELZ-0014948, ELZ-0014952, ELZ-0014962, ELZ-0014963, ELZ-0014966, ELZ-0014967, ELZ-0014970, ELZ-0014971, ELZ-0014978, ELZ-0014980, ELZ-0014984, ELZ-0014988, ELZ-0014990, ELZ-0014991, ELZ-0014993, ELZ-0014997, ELZ-0014998, ELZ-0015003, ELZ-0015004, ELZ-0015041, ELZ-0015072, ELZ-0015079, ELZ-0015086, ELZ-0015092, ELZ-0015106, ELZ-0015108, ELZ-0015109, ELZ-0015110, ELZ-0015111, ELZ-0015112, ELZ-0015115, ELZ-0015116, ELZ-0015117, ELZ-0015124, ELZ-0015137, ELZ-0015141, ELZ-0015142, ELZ-0015143, ELZ-0015147, ELZ-0015148, ELZ-0015149, ELZ-0015151, ELZ-0015153, ELZ-0015156, ELZ-0015160, ELZ-0015162, ELZ-0015171, ELZ-0015172, ELZ-0015175, ELZ-0015176, ELZ-0015177, ELZ-0015178, ELZ-0015180, ELZ-0015182, ELZ-0015183, ELZ-0015185, ELZ-0015186, ELZ-0015190, ELZ-0015191, ELZ-0015192, ELZ-0015193, ELZ-0015195, ELZ-0015196, ELZ-0015198, ELZ-0015202, ELZ-0015211, ELZ-0015254, ELZ-0015258, ELZ-0015259, ELZ-0015260, ELZ-0015261, ELZ-0015263, ELZ-0015269, ELZ-0015270, ELZ-0015272, ELZ-0015275, ELZ-0015278, ELZ-0015283, ELZ-0015287, ELZ-0015289, ELZ-0015290, ELZ-0015313, ELZ-0015314, ELZ-0015324, ELZ-0015325, ELZ-0015329, ELZ-0015356, ELZ-0015417, ELZ-0015421, ELZ-0015423, ELZ-0015424, ELZ-0015431, ELZ-0015433, ELZ-0015440, ELZ-0015477, ELZ-0015478, ELZ-0015481, ELZ-0015483, ELZ-0015484, ELZ-0015487, ELZ-0015491, ELZ-0015492, ELZ-0015493, ELZ-0015494, ELZ-0015497, ELZ-0015498, ELZ-0015499, ELZ-0015500, ELZ-0015502, ELZ-0015504, ELZ-0015505, ELZ-0015507, ELZ-0015508, ELZ-0015512, ELZ-0015513, ELZ-0015514, ELZ-0015516, ELZ-0015517, ELZ-0015518, ELZ-0015519, ELZ-0015520, ELZ-0015521, ELZ-0015522, ELZ-0015524, ELZ-0015527, ELZ-0015528, ELZ-0015530, ELZ-0015531, ELZ-0015532, ELZ-0015533, ELZ-0015534, ELZ-0015535, ELZ-0015548, ELZ-0015557, ELZ-0015563, ELZ-0015565, ELZ-0015569, ELZ-0015595, ELZ-0015596, ELZ-0015607, ELZ-0015610, ELZ-0015623, ELZ-0015636, ELZ-0015637, ELZ-0015638, ELZ-0015639, ELZ-0015640, ELZ-0015641, ELZ-0015642, ELZ-0015643, ELZ-0015644, ELZ-0015645, ELZ-0015652, ELZ-0015653, ELZ-0015695, ELZ-0015721, ELZ-0015729, ELZ-0015730, ELZ-0015733, ELZ-0015734, ELZ-0015735, ELZ-0015757, ELZ-0015761, ELZ-0015766, ELZ-0015767, ELZ-0015768, ELZ-0015769, ELZ-0015774, ELZ-0015779, ELZ-0015780, ELZ-0015796, ELZ-0015797, ELZ-0015894, ELZ-0015942, ELZ-0015977, ELZ-0015981, ELZ-0015989, ELZ-0016012, ELZ-0016014, ELZ-0016015, ELZ-0016016, ELZ-0016020, ELZ-0016021, ELZ-0016022, ELZ-0016023, ELZ-0016047, ELZ-0016050, ELZ-0016066, ELZ-0016068, ELZ-0016069, ELZ-0016070, ELZ-0016072, ELZ-0016073, ELZ-0016075, ELZ-0016079, ELZ-0016080, ELZ-0016084, ELZ-0016085, ELZ-0016086, ELZ-0016088, ELZ-0016102, ELZ-0016104, ELZ-0016109, ELZ-0016113, ELZ-0016119, ELZ-0016130, ELZ-0016133, ELZ-0016195, ELZ-0016199, ELZ-0016208, ELZ-0016238, ELZ-0016252, ELZ-0016258, ELZ-0016268, ELZ-0016270, ELZ-0016274, ELZ-0016277, ELZ-0016278, ELZ-0016279, ELZ-0016281, ELZ-0016284, ELZ-0016285, ELZ-0016304, ELZ-0016308, ELZ-0016321, ELZ-0016323, ELZ-0016327, ELZ-0016331, ELZ-0016334, ELZ-0016354, ELZ-0016363, ELZ-0016368, ELZ-0016369, ELZ-0016371, ELZ-0016374, ELZ-0016378, ELZ-0016380, ELZ-0016382, ELZ-0016383, ELZ-0016385, ELZ-0016389, ELZ-0016390, ELZ-0016391, ELZ-0016394, ELZ-0016395, ELZ-0016396, ELZ-0016397, ELZ-0016400, ELZ-0016401, ELZ-0016403, ELZ-0016405, ELZ-0016406, ELZ-0016409, ELZ-0016410, ELZ-0016411, ELZ-0016412, ELZ-0016415, ELZ-0016417, ELZ-0016420, ELZ-0016422, ELZ-0016427, ELZ-0016432, ELZ-0016462, ELZ-0016489, ELZ-0016504, ELZ-0016513, ELZ-0016516, ELZ-0016520, ELZ-0016521, ELZ-0016523, ELZ-0016527, ELZ-0016531, ELZ-0016535, ELZ-0016539, ELZ-0016542, ELZ-0016563, ELZ-0016576, ELZ-0016585, ELZ-0016586, ELZ-0016587, ELZ-0016592, ELZ-0016593, ELZ-0016594, ELZ-0016595, ELZ-0016596, ELZ-0016597, ELZ-0016599, ELZ-0016600, ELZ-0016602, ELZ-0016604, ELZ-0016606, ELZ-0016613, ELZ-0016614, ELZ-0016615, ELZ-0016616, ELZ-0016619, ELZ-0016627, ELZ-0016635, ELZ-0016636, ELZ-0016642, ELZ-0016643, ELZ-0016651, ELZ-0016655, ELZ-0016656, ELZ-0016667, ELZ-0016678, ELZ-0016679, ELZ-0016680, ELZ-0016691, ELZ-0016695, ELZ-0016696, ELZ-0016712, ELZ-0016744, ELZ-0016746, ELZ-0016757, ELZ-0016787, ELZ-0016800, ELZ-0016808, ELZ-0016818, ELZ-0016833, ELZ-0016837, ELZ-0016840, ELZ-0016841, ELZ-0016856, ELZ-0016874, ELZ-0016887, ELZ-0016890, ELZ-0016904, ELZ-0016908, ELZ-0016913, ELZ-0016918, ELZ-0016922, ELZ-0016926, ELZ-0016928, ELZ-0017493, ELZ-0017497, ELZ-0017503, ELZ-0017506, ELZ-0017508, ELZ-0017518, ELZ-0017532, ELZ-0017543, ELZ-0017600, ELZ-0017608, ELZ-0017610, ELZ-0017614, ELZ-0017616, ELZ-0017624, ELZ-0017627, ELZ-0017631, ELZ-0017675, ELZ-0017685, ELZ-0017688, ELZ-0017693, ELZ-0017694, ELZ-0017697, ELZ-0017698, ELZ-0017701, ELZ-0017710, ELZ-0017711, ELZ-0017712, ELZ-0017713, ELZ-0017714, ELZ-0017715, ELZ-0017716, ELZ-0017717, ELZ-0017718, ELZ-0017719, ELZ-0017721, ELZ-0017722, ELZ-0017727, ELZ-0017728, ELZ-0017731, ELZ-0017732, ELZ-0017734, ELZ-0017741, ELZ-0017745, ELZ-0017746, ELZ-0017749, ELZ-0017757, ELZ-0017761, ELZ-0017762, ELZ-0017765, ELZ-0017766, ELZ-0017775, ELZ-0017776, ELZ-0017806, ELZ-0017812, ELZ-0017818, ELZ-0017822, ELZ-0017844, ELZ-0017858, ELZ-0017873, ELZ-0017874, ELZ-0017883, ELZ-0017884, ELZ-0017888, ELZ-0017889, ELZ-0017892, ELZ-0017894, ELZ-0017900, ELZ-0017902, ELZ-0017903, ELZ-0017904, ELZ-0017905, ELZ-0017906, ELZ-0017907, ELZ-0017908, ELZ-0017909, ELZ-0017911, ELZ-0017913, ELZ-0017915, ELZ-0017919, ELZ-0017923, ELZ-0017932, ELZ-0017933, ELZ-0017934, ELZ-0017937, ELZ-0017940, ELZ-0017941, ELZ-0017943, ELZ-0017946, ELZ-0017947, ELZ-0017952, ELZ-0017954, ELZ-0017955, ELZ-0017958, ELZ-0017961, ELZ-0017963, ELZ-0017965, ELZ-0017966, ELZ-0017967, ELZ-0017970, ELZ-0017972, ELZ-0017977, ELZ-0017980, ELZ-0017981, ELZ-0017983, ELZ-0017987, ELZ-0017998, ELZ-0017999, ELZ-0018001, ELZ-0018008, ELZ-0018012, ELZ-0018013, ELZ-0018014, ELZ-0018018, ELZ-0018024, ELZ-0018028, ELZ-0018029, ELZ-0018032, ELZ-0018034, ELZ-0018035, ELZ-0018039, ELZ-0018041, ELZ-0018047, ELZ-0018049, ELZ-0018050, ELZ-0018053, ELZ-0018061, ELZ-0018063, ELZ-0018064, ELZ-0018074, ELZ-0018076, ELZ-0018077, ELZ-0018080, ELZ-0018083, ELZ-0018086, ELZ-0018088, ELZ-0018089, ELZ-0018094, ELZ-0018097, ELZ-0018100, ELZ-0018103, ELZ-0018107, ELZ-0018108, ELZ-0018111, ELZ-0018118, ELZ-0018129, ELZ-77135651, ELZ-77135654, ELZ-77135655, ELZ-77135657, ELZ-77135660, ELZ-77135666, ELZ-77135668, ELZ-77135670, ELZ-77135672, ELZ-77135679, ELZ-77135681, ELZ-77135684, ELZ-77135686, ELZ-77135687, ELZ-77135688, ELZ-77135689, ELZ-77135690, ELZ-77135691, ELZ-77135693, ELZ-77135694, ELZ-77135695, ELZ-77135697, ELZ-77135698, ELZ-77135699, ELZ-77135701, ELZ-77135702, ELZ-77135703, ELZ-77135704, ELZ-77135705, ELZ-77135728, ELZ-77135729, ELZ-77135730, ELZ-77135731, ELZ-77135732, ELZ-77135733, ELZ-77135734, ELZ-77135735, ELZ-77135737, ELZ-77135738, ELZ-77135739, ELZ-77135740, ELZ-77135741, ELZ-77135742, ELZ-77135743, ELZ-77135744, ELZ-77135745, ELZ-77135746, ELZ-77135747, ELZ-77135748, ELZ-77135749, ELZ-77135752, ELZ-77135824, ELZ-77135831, ELZ-77135832, ELZ-77135833, ELZ-77135834, ELZ-77135835, ELZ-77135836, ELZ-77135843, ELZ-77135844, ELZ-77135845, ELZ-77135846, ELZ-77135849, ELZ-77135878, ELZ-77135879, ELZ-77135880, ELZ-77135891, ELZ-77135903, ELZ-77135904, ELZ-77135923, ELZ-77135927, ELZ-77135928, ELZ-77135968, ELZ-77135971, ELZ-77135974, ELZ-77135975, ELZ-77135979, ELZ-77135980, ELZ-77135984, ELZ-77135986, ELZ-77135991, ELZ-77135993, ELZ-77166581, ELZ-77166583, ELZ-77166586, ELZ-77166587, ELZ-77385706, ELZ-77385716, ELZ-77385754, ELZ-77385757, ELZ-77385758, ELZ-77385780, ELZ-77385794, ELZ-77385795, ELZ-77385796, ELZ-77385798, ELZ-77385799, ELZ-77385800, ELZ-77385801, ELZ-77385802, ELZ-77385803, ELZ-77385804, ELZ-77385805, ELZ-77385806, ELZ-77385807, ELZ-77385808, ELZ-77385809, ELZ-77385810, ELZ-77385811, ELZ-77385812, ELZ-77385813, ELZ-77385814, ELZ-77385815, ELZ-77385816, ELZ-77385817, ELZ-77385818, ELZ-77385841, ELZ-77385842, ELZ-77385844, ELZ-77385848, ELZ-77385849, ELZ-77385865, ELZ-77385866, ELZ-77385867, ELZ-77385868, ELZ-77385870, ELZ-77385872, ELZ-77385873, ELZ-77385883, ELZ-77385884, ELZ-77385891, ELZ-77385942, ELZ-77385945, ELZ-77385953, ELZ-77385954, ELZ-77385958, ELZ-77385964, and ELZ-77385970.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA in the following states: AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY, and including the following countries: AUSTRALIA, AUSTRIA, CANADA, Caribbean, CZECH REPUBLIC, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED KINGDOM, and VENEZUELA.
  • 제품 설명
    Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
  • Source
    USFDA