Spacelabs Healthcare Inc: 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.

Recall number

Z-1092-2016

Recalling firm

Spacelabs Healthcare Inc

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.

Status

Terminated

Initiated

2016-02-26

Posted

not on file

Terminated

2016-10-24

Reason

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.

Root 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

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.

Lot, serial or model 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.

510(k) numbers

["K122146"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3010157426

Firm city

Snoqualmie

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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