Rappel de Device Recall Spacelabs Medical Flat Panel Display

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare, Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57370
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0620-2011
  • Date de mise en oeuvre de l'événement
    2009-03-20
  • Date de publication de l'événement
    2010-12-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2011-06-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Display, cathode-ray tube, medical - Product Code DXJ
  • Cause
    The power supply of the spacelabs medical flat panel display may fail, causing the display to go blank.
  • Action
    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

  • Modèle / numéro de série
    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, 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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, 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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, 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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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Société-mère du fabricant (2017)
  • Source
    USFDA