CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

Xhibit Central Station recalled by Spacelabs Healthcare

Spacelabs Healthcare is recalling Xhibit Central Station, distributed in 33 states. The recall was initiated on 26 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes**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.

Quantity recalledtotal 1075 units (614 units in the US and 461 outside the US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1092-2016
FDA event ID: 73393
Recalling firm: Spacelabs Healthcare, Snoqualmie, WA
Classification: Class II
Status: Terminated
Recall initiated: 26 Feb 2016
FDA classified: 10 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

26 Feb 2016	Recall initiated by company
10 Mar 2016	Classified by FDA	+13 days
16 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Michigan Minnesota Missouri Mississippi Montana North Carolina

Questions about this recall

Why was it recalled?

Which lots are affected?

**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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Spacelabs Healthcare

All 47

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Xhibit Central Station recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	Spacelabs Ultraview SL Command Module SL Command Module recalled	Spacelabs Healthcare	Packaging Defects	Nationwide
15 Apr 2026Device	CLASS II	Multi-parameter Command Module recalled by Spacelabs Healthcare	Spacelabs Healthcare	Labeling Errors	Nationwide
12 Nov 2025Device	CLASS II	Sentinel V11 recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	Branding is not applied to this product DVI display cables recalled	Spacelabs Healthcare	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide