Events

Retiro De Equipo (Recall) de Device Recall Spacelabs Medical Flat Panel Display

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Spacelabs Healthcare, Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57370
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0620-2011
  • Fecha de inicio del evento
    2009-03-20
  • Fecha de publicación del evento
    2010-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95976
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Display, cathode-ray tube, medical - Product Code DXJ
  • Causa
    The power supply of the spacelabs medical flat panel display may fail, causing the display to go blank.
  • Acción
    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

Device Recall Spacelabs Medical Flat Panel Display
  • Modelo / Serial
    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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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA