Class 2 Device Recall Spacelabs Healthcare Xhibit Central Station

• Date Initiated by Firm: February 26, 2016
• Create Date: March 10, 2016
• Recall Status: Terminated on October 24, 2016
• Recall Number: Z-1092-2016
• Recall Event ID: 73393
• 510(K)Number: K122146
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: 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.
• Code Information: **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.
• Recalling Firm/ Manufacturer: Spacelabs Healthcare Inc; 35301 SE Center St; Snoqualmie WA 98065-9216
• For Additional Information Contact: Technical Support; 425-396-3300
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software in the Use Environment
• 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.
• Quantity in Commerce: total 1075 units (614 units in the US and 461 outside the US)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MHX