Rappel de Device Recall Spacelabs Healthcare Xhibit Central Station

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 Inc.

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
    73393
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1092-2016
  • Date de mise en oeuvre de l'événement
    2016-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2016-10-24
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    The firm has received one report of values for patient height and weight being switched when input at the xhibit central station, model 96102, causing a bedside monitor body surface area (bsa) calculation to be in error.
  • Action
    Spacelabs sent the letter Urgent Medical Device Correction -Spacelabs Healthcare Inc. - Xhibit Central Station, Model 96102, dated 26 February 2016 to US consignees. The firm will send a notification letter to international consignees on March 4, 2016. Consignees who have any questions about this corrective action, please contact Spacelabs at 1-800-522-7025 and select 2 for Technical Support.

Device

  • Modèle / numéro de série
    **SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US*******  SALA0315F01025, SLA0114F00426, SLA0114F00434, SLA0114F00435, SLA0114F00444, SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0114F00448, SLA0114F00449, SLA0114F00451, SLA0114F00452, SLA0114F00453, SLA0114F00454, SLA0114F00457, SLA0114F00458, SLA0114F00460, SLA0114F00461, SLA0114F00462, SLA0114F00463, SLA0114F00464, SLA0114F00466, SLA0114F00468, SLA0114F00469, SLA0115F00916, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00925, SLA0115F00926, SLA0115F00927, SLA0115F00928, SLA0115F00929, SLA0115F00931, SLA0115F00933, SLA0115F00934, SLA0115F00935, SLA0115F00936, SLA0115F00937, SLA0115F00948, SLA0115F00950, SLA0115F00955, SLA0115F00959, SLA0115F00961, SLA0115F00963, SLA0115F00964, SLA0115F00968, SLA0115F00969, SLA0115F00971, SLA0115F00972, SLA0115F00976, SLA0115F00979, SLA0115F00983, SLA0115F00986, SLA0115F00987, SLA0115F00991, SLA0115F00993, SLA0124F00910, SLA0214F00484, SLA0214F00485, SLA0214F00486, SLA0214F00489, SLA0214F00492, SLA0214F00493, SLA0214F00494, SLA0214F00497, SLA0214F00499, SLA0214F00501, SLA0214F00520, SLA0214F00521, SLA0214F00522, SLA0214F00525, SLA0214F00527, SLA0314F00529, SLA0314F00530, SLA0314F00531, SLA0314F00532, SLA0314F00534, SLA0314F00535, SLA0314F00536, SLA0314F00537, SLA0314F00538, SLA0314F00539, SLA0314F00539, SLA0314F00540, SLA0314F00542, SLA0314F00543, SLA0314F00544, SLA0314F00545, SLA0314F00546, SLA0314F00547, SLA0314F00548, SLA0314F00549, SLA0314F00550, SLA0314F00551, SLA0314F00551, SLA0314F00552, SLA0314F00553, SLA0314F00556, SLA0314F00557, SLA0314F00558, SLA0314F00559, SLA0314F00561, SLA0314F00562, SLA0314F00563, SLA0314F00565, SLA0314F00567, SLA0315F01027, SLA0315F01030, SLA0315F01031, SLA0315F01032, SLA0315F01033, SLA0315F01034, SLA0315F01035, SLA0315F01038, SLA0315F01039, SLA0315F01040, SLA0315F01041, SLA0315F01042, SLA0315F01043, SLA0315F01044, SLA0315F01045, SLA0315F01046, SLA0315F01047, SLA0315F01048, SLA0315F01049, SLA0315F01050, SLA0315F01051, SLA0315F01052, SLA0315F01053, SLA0315F01054, SLA0315F01055, SLA0315F01056, SLA0315F01057, SLA0315F01061, SLA0315F01062, SLA0315F01064, SLA0315F01065, SLA0315F01066, SLA0414F00568, SLA0414F00569, SLA0414F00570, SLA0414F00571, SLA0414F00572, SLA0414F00573, SLA0414F00574, SLA0414F00577, SLA0414F00583, SLA0414F00585, SLA0414F00597, SLA0414F00598, SLA0414F00599, SLA0414F00600, SLA0414F00603, SLA0414F00610, SLA0415F01077, SLA0415F01078, SLA0415F01079, SLA0415F01080, SLA0415F01081, SLA0415F01082, SLA0415F01083, SLA0415F01084, SLA0415F01085, SLA0415F01086, SLA0415F01087, SLA0415F01089, SLA0415F01090, SLA0415F01091, SLA0415F01092, SLA0415F01093, SLA0512F00204, SLA0515F01104, SLA0515F01105, SLA0515F01106, SLA0515F01107, SLA0515F01108, SLA0515F01110, SLA0515F01111, SLA0515F01112, SLA0515F01113, SLA0515F01114, SLA0515F01115, SLA0515F01116, SLA0515F01117, SLA0515F01118, SLA0515F01119, SLA0515F01120, SLA0515F01121, SLA0515F01123, SLA0515F01124, SLA0515F01125, SLA0515F01126, SLA0515F01127, SLA0515F01128, SLA0515F01129, SLA0515F01130, SLA0515F01131, SLA0515F01133, SLA0515F01134, SLA0515F01135, SLA0515F01136, SLA0515F01137, SLA0515F01140, SLA0515F01142, SLA0515F01143, SLA0515F01144, SLA0515F01145, SLA0515F01146, SLA0515F01147, SLA0515F01148, SLA0515F01149, SLA0515F01150, SLA0515F01151, SLA0515F01152, SLA0515F01153, SLA0515F01154, SLA0515F01155, SLA0515F01156, SLA0515F01157, SLA0515F01158, SLA0515F01159, SLA0515F01160, SLA0515F01161, SLA0515F01162, SLA0515F01163, SLA0515F01164, SLA0515F01165, SLA0515F01166, SLA0515F01167, SLA0515F01168, SLA0515F01169, SLA0515F01170, SLA0515F01171, SLA0515F01172, SLA0515F01173, SLA0515F01174, SLA0515F01175, SLA0515F01176, SLA0515F01177, SLA0515F01178, SLA0515F01179, SLA0515F01180, SLA0515F01181, SLA0515F01182, SLA0515F01183, SLA0614F00618, SLA0614F00619, SLA0614F00620, SLA0614F00622, SLA0614F00623, SLA0614F00624, SLA0614F00625, SLA0614F00627, SLA0614F00628, SLA0614F00629, SLA0614F00631, SLA0614F00633, SLA0614F00635, SLA0614F00636, SLA0614F00637, SLA0614F00638, SLA0614F00639, SLA0614F00640, SLA0614F00641, SLA0614F00642, SLA0614F00643, SLA0614F00644, SLA0614F00645, SLA0614F00649, SLA0614F00650, SLA0614F00651, SLA0614F00652, SLA0614F00654, SLA0614F00655, SLA0614F00656, SLA0614F00657, SLA0615F01187, SLA0615F01188, SLA0615F01190, SLA0615F01191, SLA0615F01192, SLA0615F01193, SLA0615F01194, SLA0615F01196, SLA0615F01197, SLA0615F01198, SLA0615F01199, SLA0615F01200, SLA0615F01201, SLA0615F01202, SLA0615F01209, SLA0615F01212, SLA0615F01213, SLA0615F01217, SLA0615F01219, SLA0615F01223, SLA0615F01226, SLA0615F01229, SLA0615F01231, SLA0615F01232, SLA0615F01233, SLA0615F01234, SLA0615F01235, SLA0615F01236, SLA0615F01237, SLA0615F01238, SLA0615F01239, SLA0615F01240, SLA0615F01242, SLA0615F01244, SLA0615F01246, SLA0615F01248, SLA0615F01249, SLA0615F01254, SLA0615F01255, SLA0615F01256, SLA0615F01261, SLA0615F01262, SLA0615F01263, SLA0615F01264, SLA0714F00678, SLA0714F00685, SLA0714F00687, SLA0714F00688, SLA0714F00694, SLA0714F00696, SLA0714F00702, SLA0714F00703, SLA0714F00704, SLA0715F01274, SLA0715F01275, SLA0715F01279, SLA0715F01285, SLA0715F01286, SLA0715F01288, SLA0715F01290, SLA0715F01293, SLA0715F01294, SLA0715F01296, SLA0715F01310, SLA0715F01314, SLA0715F01316, SLA0715F01317, SLA0715F01323, SLA0715F01324, SLA0715F01325, SLA0715F01326, SLA0715F01327, SLA0715F01328, SLA0715F01329, SLA0715F01334, SLA0715F01336, SLA0715F01337, SLA0715F01346, SLA0715F01347, SLA0715F01348, SLA0814F00707, SLA0814F00708, SLA0814F00713, SLA0814F00722, SLA0814F00723, SLA0814F00724, SLA0814F00726, SLA0814F00728, SLA0814F00732, SLA0814F00743, SLA0814F00744, SLA0814F00750, SLA0815F01331, SLA0815F01371, SLA0815F01372, SLA0815F01373, SLA0815F01374, SLA0815F01375, SLA0815F01376, SLA0815F01379, SLA0815F01380, SLA0815F01381, SLA0815F01382, SLA0815F01383, SLA0815F01384, SLA0815F01385, SLA0815F01386, SLA0815F01387, SLA0815F01388, SLA0815F01390, SLA0815F01391, SLA0815F01392, SLA0815F01395, SLA0815F01397, SLA0815F01399, SLA0815F01400, SLA0815F01401, SLA0815F01402, SLA0815F01403, SLA0815F01404, SLA0815F01405, SLA0815F01406, SLA0815F01407, SLA0815F01408, SLA0815F01409, SLA0815F01412, SLA0815F01413, SLA0815F01414, SLA0815F01415, SLA0815F01416, SLA0815F01418, SLA0815F01419, SLA0815F01421, SLA0815F01424, SLA0815F01426, SLA0915F01439, SLA0915F01440, SLA0915F01442, SLA0915F01443, SLA0915F01447, SLA0915F01448, SLA0915F01449, SLA0915F01451, SLA0915F01452, SLA0915F01453, SLA0915F01455, SLA0915F01457, SLA0915F01459, SLA0915F01462, SLA0915F01463, SLA0915F01468, SLA0915F01470, SLA0915F01471, SLA0915F01474, SLA0915F01475, SLA0915F01477, SLA0915F01482, SLA0915F01483, SLA0915F01493, SLA0915F01494, SLA0915F01496, SLA0915F01497, SLA0915F01498, SLA0915F01499, SLA0915F01500, SLA0915F01501, SLA0915F01502, SLA0915F01503, SLA0915F01505, SLA0915F01506, SLA0915F01507, SLA0915F01508, SLA0915F01510, SLA0915F01511, SLA0915F01512, SLA0915F01513, SLA0915F01514, SLA0915F01516, SLA1014F00755, SLA1014F00758, SLA1014F00760, SLA1014F00761, SLA1014F00762, SLA1014F00763, SLA1014F00767, SLA1014F00771, SLA1014F00772, SLA1014F00773, SLA1014F00774, SLA1014F00775, SLA1014F00778, SLA1014F00779, SLA1014F00782, SLA1014F00784, SLA1015F01524, SLA1015F01525, SLA1015F01527, SLA1015F01528, SLA1015F01530, SLA1015F01534, SLA1015F01535, SLA1015F01536, SLA1015F01537, SLA1015F01538, SLA1015F01539, SLA1015F01540, SLA1015F01542, SLA1015F01544, SLA1015F01546, SLA1015F01547, SLA1015F01551, SLA1015F01552, SLA1015F01553, SLA1015F01555, SLA1015F01556, SLA1015F01557, SLA1015F01558, SLA1015F01560, SLA1015F10554, SLA11122F00284, SLA1112F00284, SLA1113F00347, SLA1113F00349, SLA1113F00350, SLA1113F00351, SLA1113F00352, SLA1113F00355, SLA1113F00356, SLA1113F00357, SLA1113F00358, SLA1113F00359, SLA1113F00363, SLA1113F00364, SLA1113F00365, SLA1113F00366, SLA1113F00367, SLA1113F00369, SLA1113F00370, SLA1113F00371, SLA1113F00372, SLA1113F00376, SLA1113F00377, SLA1113F00379, SLA1113F00381, SLA1113F00383, SLA1113F00384, SLA1113F00385, SLA1114F00794, SLA1114F00795, SLA1114F00796, SLA1114F00797, SLA1114F00798, SLA1114F00799, SLA1114F00801, SLA1114F00802, SLA1114F00808, SLA1114F00809, SLA1114F00810, SLA1114F00811, SLA1114F00812, SLA1114F00814, SLA1114F00815, SLA1114F00816, SLA1114F00817, SLA1114F00818, SLA1114F00819, SLA1114F00820, SLA1114F00823, SLA1114F00824, SLA1114F00825, SLA1114F00826, SLA1114F00827, SLA1114F00828, SLA1114F00829, SLA1114F00833, SLA1115F01571, SLA1115F01574, SLA1115F01576, SLA1115F01578, SLA1115F01579, SLA1115F01582, SLA1115F01583, SLA1115F01584, SLA1115F01587, SLA1115F01588, SLA1115F01590, SLA1115F01600, SLA1115F01607, SLA1213F00391, SLA1213F00392, SLA1213F00394, SLA1213F00398, SLA1213F00401, SLA1213F00402, SLA1213F00403, SLA1213F00409, SLA1213F00411, SLA1213F00412, SLA1213F00414, SLA1213F00415, SLA1213F00416, SLA1213F00417, SLA1213F00420, SLA1213F00421, SLA1213F00422, SLA1213F00423, SLA1213F00424, SLA1213F00425, SLA1214F00837, SLA1214F00841, SLA1214F00844, SLA1214F00846, SLA1214F00858, SLA1214F00866, SLA1214F00871, SLA1214F00874, SLA1214F00876, SLA1214F00877, SLA1214F00878, SLA1214F00881, SLA1214F00882, SLA1214F00885, SLA1214F00886, SLA1214F00887, SLA1214F00889, SLA1214F00893, SLA1214F00894, SLA1214F00898, SLA1214F00899, SLA1214F00903, SLA1214F00905, SLA1214F00909, SLA1214F00912, and SLA1215F01640.    ***********SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE US*****  SLA0114F00430, SLA0114F00431, SLA0114F00432, SLA0114F00433, SLA0114F00436, SLA0114F00437, SLA0114F00438, SLA0114F00439, SLA0114F00440, SLA0114F00442, SLA0114F00443, SLA0114F00450, SLA0114F00459, SLA0114F00465, SLA0114F00467, SLA0115F00922, SLA0115F00930, SLA0115F00938, SLA0115F00939, SLA0115F00943, SLA0115F00945, SLA0115F00951, SLA0115F00960, SLA0115F00962, SLA0115F00966, SLA0115F00967, SLA0115F00970, SLA0115F00973, SLA0115F00974, SLA0115F00975, SLA0115F00977, SLA0115F00980, SLA0115F00981, SLA0115F00982, SLA0115F00984, SLA0115F00985, SLA0115F00988, SLA0115F00989, SLA0115F00990, SLA0115F00992, SLA0214F00491, SLA0214F00496, SLA0214F00500, SLA0214F00502, SLA0214F00503, SLA0214F00505, SLA0214F00507, SLA0214F00508, SLA0214F00511, SLA0214F00513, SLA0214F00515, SLA0214F00517, SLA0214F00519, SLA0214F00523, SLA0214F00524, SLA0214F00526, SLA0314F00528, SLA0314F00541, SLA0314F00554, SLA0314F00555, SLA0314F00560, SLA0314F00564, SLA0314F00566, SLA0315F01022, SLA0315F01023, SLA0315F01024, SLA0315F01026, SLA0315F01028, SLA0315F01036, SLA0315F01037, SLA0315F01058, SLA0315F01059, SLA0315F01060, SLA0315F01063, SLA0414F00576, SLA0414F00578, SLA0414F00579, SLA0414F00580, SLA0414F00581, SLA0414F00582, SLA0414F00586, SLA0414F00587, SLA0414F00594, SLA0414F00595, SLA0414F00596, SLA0414F00601, SLA0414F00605, SLA0414F00606, SLA0414F00607, SLA0414F00608, SLA0414F00609, SLA0414F00611, SLA0414F00612, SLA0414F00613, SLA0512F000202, SLA0512F00183, SLA0512F00185, SLA0512F00186, SLA0512F00187, SLA0512F00188, SLA0512F00189, SLA0512F00190, SLA0512F00191, SLA0512F00192, SLA0512F00195, SLA0512F00196, SLA0512F00197, SLA0512F00203, SLA0512F00206, SLA0512F00207, SLA0512F00208, SLA0512F00209, SLA0512F00210, SLA0512F00211, SLA0512F00213, SLA0515F01109, SLA0515F01132, SLA0515F01138, SLA0515F01139, SLA0612F00217, SLA0612F00218, SLA0612F00219, SLA0612F00221, SLA0612F00223, SLA0612F00224, SLA0612F00225, SLA0612F00226, SLA0612F00227, SLA0612F00228, SLA0612F00229, SLA0612F00230, SLA0612F00231, SLA0612F00232, SLA0612F00233, SLA0612F00235, SLA0612F00236, SLA0612F00237, SLA0612F00238, SLA0612F00239, SLA0612F00240, SLA0612F00241, SLA0612F00243, SLA0612F00245, SLA0612F00248, SLA0612F00249, SLA0612F00251, SLA0612F00252, SLA0612F00253, SLA0612F00255, SLA0612F00256, SLA0612F00263, SLA0612F00264, SLA0612F00265, SLA0612F00266, SLA0612F00268, SLA0612F00272, SLA0612F00273, SLA0614F00621, SLA0614F00632, SLA0614F00634, SLA0614F00647, SLA0614F00653, SLA0615F01186, SLA0615F01189, SLA0615F01195, SLA0615F01203, SLA0615F01205, SLA0615F01206, SLA0615F01207, SLA0615F01208, SLA0615F01210, SLA0615F01211, SLA0615F01215, SLA0615F01216, SLA0615F01218, SLA0615F01220, SLA0615F01221, SLA0615F01222, SLA0615F01224, SLA0615F01225, SLA0615F01227, SLA0615F01228, SLA0615F01230, SLA0615F01245, SLA0714F00667, SLA0714F00668, SLA0714F00669, SLA0714F00670, SLA0714F00671, SLA0714F00672, SLA0714F00673, SLA0714F00674, SLA0714F00675, SLA0714F00676, SLA0714F00677, SLA0714F00679, SLA0714F00680, SLA0714F00681, SLA0714F00682, SLA0714F00683, SLA0714F00684, SLA0714F00690, SLA0714F00691, SLA0714F00692, SLA0714F00693, SLA0714F00695, SLA0714F00697, SLA0714F00698, SLA0714F00699, SLA0714F00700, SLA0714F00701, SLA0714F00705, SLA0714F00706, SLA0715F01270, SLA0715F01271, SLA0715F01273, SLA0715F01276, SLA0715F01277, SLA0715F01278, SLA0715F01280, SLA0715F01281, SLA0715F01282, SLA0715F01283, SLA0715F01284, SLA0715F01287, SLA0715F01289, SLA0715F01291, SLA0715F01292, SLA0715F01295, SLA0715F01297, SLA0715F01298, SLA0715F01299, SLA0715F01300, SLA0715F01303, SLA0715F01305, SLA0715F01306, SLA0715F01307, SLA0715F01308, SLA0715F01309, SLA0715F01311, SLA0715F01312, SLA0715F01318, SLA0715F01319, SLA0715F01320, SLA0715F01321, SLA0715F01322, SLA0715F01333, SLA0715F01335, SLA0715F01339, SLA0715F01340, SLA0715F01341, SLA0715F01342, SLA0715F01343, SLA0715F01344, SLA0715F01345, SLA0715F01349, SLA0715F01354, SLA0715F01355, SLA0715F01357, SLA0715F01358, SLA0715F01360, SLA0715F01368, SLA0814F00709, SLA0814F00710, SLA0814F00711, SLA0814F00712, SLA0814F00714, SLA0814F00715, SLA0814F00716, SLA0814F00718, SLA0814F00719, SLA0814F00720, SLA0814F00721, SLA0814F00725, SLA0814F00729, SLA0814F00731, SLA0814F00733, SLA0814F00734, SLA0814F00735, SLA0814F00736, SLA0814F00737, SLA0814F00738, SLA0814F00739, SLA0814F00740, SLA0814F00741, SLA0814F00742, SLA0814F00745, SLA0814F00746, SLA0814F00751, SLA0815F01396, SLA0815F01410, SLA0815F01411, SLA0815F01417, SLA0815F01420, SLA0815F01423, SLA0815F01427, SLA0815F01428, SLA0815F01429, SLA0815F01430, SLA0815F01432, SLA0815F01433, SLA0915F01438, SLA0915F01441, SLA0915F01444, SLA0915F01445, SLA0915F01446, SLA0915F01450, SLA0915F01454, SLA0915F01456, SLA0915F01458, SLA0915F01460, SLA0915F01464, SLA0915F01466, SLA0915F01467, SLA0915F01469, SLA0915F01472, SLA0915F01473, SLA0915F01476, SLA0915F01478, SLA0915F01479, SLA0915F01480, SLA0915F01481, SLA0915F01484, SLA0915F01485, SLA0915F01486, SLA0915F01487, SLA0915F01488, SLA0915F01489, SLA0915F01490, SLA0915F01491, SLA0915F01492, SLA0915F01495, SLA0915F01504, SLA0915F01509, SLA0915F01515, SLA0915F01517, SLA1014F00754, SLA1014F00756, SLA1014F00757, SLA1014F00759, SLA1014F00764, SLA1014F00765, SLA1014F00766, SLA1014F00769, SLA1014F00770, SLA1014F00776, SLA1014F00777, SLA1014F00780, SLA1014F00781, SLA1014F00783, SLA1014F00785, SLA1014F00787, SLA1014F00789, SLA1014F00790, SLA1014F00791, SLA1014F00792, SLA1014F00793, SLA1015F01523, SLA1015F01526, SLA1015F01529, SLA1015F01531, SLA1015F01532, SLA1015F01533, SLA1015F01543, SLA1015F01545, SLA1015F01548, SLA1015F01549, SLA1015F01550, SLA1015F01559, SLA1015F01561, SLA1015F01562, SLA1113F00348, SLA1113F00353, SLA1113F00354, SLA1113F00360, SLA1113F00361, SLA1113F00362, SLA1113F00368, SLA1113F00373, SLA1113F00374, SLA1113F00378, SLA1113F00382, SLA1114F00800, SLA1114F00821, SLA1114F00830, SLA1114F00831, SLA1114F00832, SLA1115F01572, SLA1115F01573, SLA1115F01575, SLA1115F01577, SLA1115F01580, SLA1115F01585, SLA1115F01586, SLA1115F01589, SLA1115F01591, SLA1115F01601, SLA1115F01604, SLA1115F01605, SLA1213F00386, SLA1213F00388, SLA1213F00389, SLA1213F00390, SLA1213F00393, SLA1213F00395, SLA1213F00396, SLA1213F00397, SLA1213F00399, SLA1213F00408, SLA1213F00413, SLA1213F00419, SLA1214F00836, SLA1214F00838, SLA1214F00839, SLA1214F00840, SLA1214F00842, SLA1214F00843, SLA1214F00847, SLA1214F00848, SLA1214F00849, SLA1214F00850, SLA1214F00851, SLA1214F00853, SLA1214F00854, SLA1214F00855, SLA1214F00856, SLA1214F00859, SLA1214F00860, SLA1214F00861, SLA1214F00862, SLA1214F00863, SLA1214F00864, SLA1214F00867, SLA1214F00868, SLA1214F00869, SLA1214F00870, SLA1214F00872, SLA1214F00873, SLA1214F00875, SLA1214F00879, SLA1214F00880, SLA1214F00883, SLA1214F00884, SLA1214F00888, SLA1214F00890, SLA1214F00891, SLA1214F00892, SLA1214F00895, SLA1214F00897, SLA1214F00900, SLA1214F00901, SLA1214F00902, SLA1214F00904, SLA1214F00907, SLA1214F00911, SLA1214F00913, SLA1214F00914, SLA1214F00915, SLA1215F01633, SLA123F00393, and SLA515F01141.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    distributed in AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WY and Guam and in the following countries AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, EL SALVADOR, FRANCE, GERMANY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ITALY, KUWAIT, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and UNITED KINGDOM.
  • Description du dispositif
    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Société-mère du fabricant (2017)
  • Source
    USFDA