Device Recall CARESCAPE R860 ventilators with software version 10SP05

  • Model / Serial
    Lot / Serials #'s: 103841473, 103725811-1, 103725811-2, CBRW01546, CBRW01547, CBRU02110, CBRV00344, CBRV02569, CBRV00298, 103721045, 103808843, CBRV03050, CBRV03054, CBRV03056, CBRV03063, CBRV03064, CBRV03071, CBRV03072, CBRV03073, CBRW00417,  CBRW00419, CBRW00424, CBRW00441, CBRW00443, CBRW00458, CBRW00460, CBRW00461, CBRW02306, CBRW02627, CBRW02629, 103721436, CBRU02450, CBRW01735, CBRW01044, CBRW01048, CBRW01049, CBRW01051, CBRW01052, CBRW01053, CBRW01056, CBRW01057, CBRW01059, CBRW01061, CBRW01062, CBRW01063, CBRW01075, CBRW01076, CBRW01077, CBRW01232, CBRW01814, CBRW01410, CBRW01412, 103798917, CBRW01918, CBRV02578,  CBRW02442, CBRW02449, CBRW01830, CBRW01833, CBRW01838, CBRW01839, CBRW01849, CBRW01860, CBRW01889, CBRW01895, CBRW01896, CBRW01897, CBRW01898, CBRW01899, CBRW01900, CBRW01902, CBRW01903, CBRW01904, CBRW01905, CBRW01906, CBRW01909, CBRW01932, CBRV01459, 103730032, 103721104, CBRW01244, CBRW02420, CBRW01347, 103771244, CBRW02661, CBRU02452, 11495021, 70175736-1, 70175736-10, 70175736-100, 70175736-101, 70175736-102, 70175736-103, 70175736-104, 70175736-105, 70175736-106, 70175736-107, 70175736-108, 70175736-109, 70175736-11, 70175736-110, 70175736-111, 70175736-112, 70175736-113, 70175736-114, 70175736-115, 70175736-116, 70175736-117, 70175736-118, 70175736-119, 70175736-12, 70175736-120, 70175736-121, 70175736-122, 70175736-123, 70175736-124, 70175736-125, 70175736-126, 70175736-127, 70175736-128,  70175736-129, 70175736-13, 70175736-130, 70175736-131, 70175736-132, 70175736-133, 70175736-134, 70175736-135, 70175736-136, 70175736-137, 70175736-138, 70175736-139, 70175736-14, 70175736-140, 70175736-141, 70175736-142, 70175736-143, 70175736-144, 70175736-145, 70175736-146, 70175736-147, 70175736-148, 70175736-149, 70175736-15, 70175736-150, 70175736-151, 70175736-152, 70175736-153, 70175736-154, 70175736-155, 70175736-156, 70175736-157, 70175736-158, 70175736-159, 70175736-16, 70175736-160, 70175736-161, 70175736-162, 70175736-163, 70175736-164, 70175736-165, 70175736-166, 70175736-167, 70175736-168, 70175736-169, 70175736-17, 70175736-170, 70175736-171, 70175736-172, 70175736-173, 70175736-174, 70175736-175, 70175736-176, 70175736-177, 70175736-178, 70175736-179, 70175736-18, 70175736-180, 70175736-181, 70175736-182, 70175736-183, 70175736-184, 70175736-185, 70175736-186, 70175736-187, 70175736-188, 70175736-189, 70175736-19, 70175736-190, 70175736-191, 70175736-192, 70175736-193, 70175736-194, 70175736-195, 70175736-196, 70175736-197, 70175736-198, 70175736-199, 70175736-2, 70175736-20, 70175736-200, 70175736-21, 70175736-22, 70175736-23, 70175736-24, 70175736-25, 70175736-26, 70175736-27, 70175736-28, 70175736-29, 70175736-3, 70175736-30, 70175736-31, 70175736-32, 70175736-33, 70175736-34, 70175736-35, 70175736-36, 70175736-37, 70175736-38, 70175736-39, 70175736-4, 70175736-40, 70175736-41, 70175736-42, 70175736-43, 70175736-44, 70175736-45, 70175736-46, 70175736-47, 70175736-48, 70175736-49, 70175736-5, 70175736-50, 70175736-51, 70175736-52, 70175736-53, 70175736-54, 70175736-55, 70175736-56, 70175736-57, 70175736-58, 70175736-59, 70175736-6, 70175736-60, 70175736-61, 70175736-62, 70175736-63, 70175736-64, 70175736-65, 70175736-66, 70175736-67, 70175736-68, 70175736-69, 70175736-7,  70175736-70, 70175736-71, 70175736-72, 70175736-73, 70175736-74, 70175736-75, 70175736-76, 70175736-77, 70175736-78, 70175736-79, 70175736-8, 70175736-80, 70175736-81, 70175736-82, 70175736-83,  70175736-84, 70175736-85, 70175736-86, 70175736-87, 70175736-88,  70175736-89, 70175736-9, 70175736-90, 70175736-91, 70175736-92, 70175736-93, 70175736-94, 70175736-95, 70175736-96, 70175736-97, 70175736-98, 70175736-99, 103725706, CBRW02482, 103721074, CBRW01588, CBRW02287, 103721038, CBRW01151, CBRW01152,  CBRW01155, CBRW01156, CBRW01157, CBRW01158, 103737388, CBRU02113, CBRU02114, CBRU02124, CBRU02126, CBRU02128, CBRU02135, CBRU02143, CBRU02454, CBRU02456, CBRV01435,  CBRV01436, CBRV01438, CBRV01449, CBRV01451, CBRV01453,  CBRV02039, CBRV02117, CBRV02156, CBRV02179, CBRV02188, CBRV02199, CBRV02540, CBRV02542, CBRV02563, CBRV02570, CBRV02571, CBRV02579, CBRV02583, CBRV02584, CBRV01458, CBRV02025, CBRW00442, CBRW00459, CBRW01055, CBRW01058, CBRW01074, 11494687, 103722840, 103771194, 103785995-1,  103785995-2, 103785995-3, 103785995-4, 103785995-5, 11466039-1, 11466039-2, 11466039-3, 11466039-4, 11466039-5, CBRW01437, CBRW01448, 11485242-1, 11485242-2, CBRW01112, CBRW01464, CBRW01797, CBRW01799, CBRW01800, CBRW01810, CBRW01831, CBRW01842, CBRW01846, CBRW01866, CBRW01867, CBRW01868,  CBRW01869, CBRW01878, CBRW01879, CBRW01880, CBRW01881, CBRW01882, CBRW01883, CBRW01809, CBRW01934, CBRW01937, CBRW01946, CBRW01947, CBRW01948, 6527249, 6528751, 6526140-1 6526140-2, 6528030-1, 6528030-2, 6528030-3, CBRW01401, CBRW01439, CBRW01964, CBRW01965, CBRW01971, CBRW01972, CBRW01974,  CBRW02707, CBRW02735, CBRW02753, CBRV02796, CBRW01328,  CBRW01771, CBRW01783, CBRW01794, CBRW01795, CBRW01796, CBRW01798, CBRW01802, CBRW01807, CBRW01767, CBRW01768, CBRW01770, CBRW01772, CBRW02562, CBRW02573, CBRW02574, CBRW02575, CBRW02576, CBRW02577, CBRW02578, CBRW02579, CBRW02580, CBRW02581, CBRW02582, CBRW02583, CBRW02584, CBRW02585, CBRW02586, CBRW02587, CBRW02588, CBRW02598, CBRW02599, CBRW02600, CBRW02601, CBRW02602, CBRW02603, CBRW02614, CBRW02615, CBRW02617, CBRW02631, CBRW02632, CBRW02634, CBRW02635, CBRW02636, CBRW02637, CBRW02638, CBRW02639, CBRW02640, CBRW02641, CBRW02642, CBRW01147, CBRW01149, CBRW01573, CBRW01891, CBRW01892, CBRW01893,  CBRW01894, CBRW02605, CBRW02606, CBRW02608, CBRW02609, CBRW02610, CBRW02612, CBRW02613, CBRW02616CBRW02421, CBRW02422, CBRW02424, CBRW02425, CBRW01983, CBRW01992, CBRW01644, CBRW01645, CBRW01658, CBRW01413, CBRW01414, CBRW01582, CBRW01586, CBRW02301, CBRW02304, CBRW02305, CBRW02307, CBRW02308, CBRW02309, CBRW02310, CBRW02311, CBRW02312, CBRW02314, CBRW02506, CBRW02507, CBRW02563, CBRW02564, CBRW02659, CBRW02660, CBRW02696, CBRW02697, CBRW02698, CBRW02757, CBRW02758, CBRW02772, CBRW02773, CBRW02774, CBRW00934, CBRW00935, CBRW00936, CBRW00937, CBRW00938, CBRW00939, CBRW00940, CBRW01634, CBRW01669, CBRW01901, CBRW01907, CBRW01908, CBRW01910, CBRW01911, CBRW01912, CBRW01913, CBRW01914, CBRW01915, CBRW01916, CBRW01917, CBRW01919, CBRW01920, CBRW01921, CBRW01922, CBRW01923, CBRW01924, CBRW01925, CBRW01926, CBRW01927, CBRW00942, CBRW00943, CBRW00944, CBRW02713, CBRW02763, CBRW02764, CBRW02786, CBRW02810, CBRW02526, CBRU00173, 10190157, 10190159, 10191029, 10193770, 10194582, CBRU00498, CBRU00509, CBRU00512, CBRU00517, CBRU00522, CBRU00523, CBRU00540, CBRU00541, CBRU00550, CBRU00551, CBRU00552, CBRU00553, CBRU00554, CBRU00555, CBRU00559, CBRU00560, CBRU00561, CBRU00562, CBRU00563, CBRU00565, CBRU00566, CBRU00567, CBRU00568, CBRU00569, CBRU00570, CBRU00571, CBRU00572, CBRU00573, CBRU00574, CBRU00575, CBRU00577, CBRU00579, CBRU00580, CBRU00581, CBRU00593, CBRU00594, CBRU00595, CBRU00596, CBRU00597, CBRU00598, CBRU00599, CBRU00600, CBRU00601, CBRU00602, CBRU00603, CBRU00604, CBRU00605, CBRU00606, CBRU00607, CBRU00608, CBRU00613, CBRU00614, CBRU00619, CBRU00620, CBRU00621, CBRU00622, CBRU00624, CBRW00918, CBRW02249, CBRW00919, CBRW01284, CBRW01570, CBRW01630, 11484134, CBRW01604, CBRW01856,  CBRW01857, CBRW01858, CBRW01375, CBRW01447, CBRW01619, CBRW01715, CBRW01742, CBRW01746, CBRW01753, CBRW01754,  CBRW01755, CBRW01757, CBRW01758, CBRW01804, CBRW01805, CBRW01808, CBRW01820, CBRW01821, CBRW01823, CBRW01824, CBRW01825, CBRW01827, CBRW01834, CBRW01835, CBRW01836, CBRW02023, CBRW02046, CBRW02048, CBRW02049, CBRW02053, CBRW02055, CBRW02056, CBRW02060, CBRW02061, CBRW02063, CBRW02064, CBRW02065, CBRW02066, CBRW02067, CBRW02069, CBRW02070, CBRW02071, CBRW02072, CBRW02073, CBRW02074, CBRW02075, CBRW02076, CBRW02077, CBRW02078, CBRW02079, CBRW02080, CBRW02081, CBRW02082, CBRW02083, CBRW02084, CBRW02085, CBRW02086, CBRW02087, CBRW02088, CBRW02089, CBRW02090, CBRW02091, CBRW02092, CBRW02093, CBRW02094, CBRW02095, CBRW02096, CBRW02097, CBRW02098, CBRW02099, CBRW02100, CBRW02102, CBRW02105, CBRW02107, CBRW02108, CBRW02109, CBRW02110, CBRW02114, CBRW02115, CBRW02120, CBRW02122, CBRW02123, CBRW02124, CBRW02125, CBRW02126, CBRW02127, CBRW02128, CBRW02129, CBRW02130, CBRW02131, CBRW02144, CBRW02145, CBRW02146, CBRW02147, CBRW02216, CBRW02611, CBRW02633, CBRW02648, CBRW02652, CBRW02653, CBRW02654, CBRW02655, CBRW02656, CBRW02657, CBRW02658, CBRW02676, CBRW02677, CBRW02678, CBRW02679, CBRW02684, CBRW02686, CBRW02687, CBRW02688, CBRW02689, CBRW02690, CBRW02693, CBRW02694, CBRW02695, CBRW02699, CBRW02700, CBRW02702, CBRW02037, CBRW02051, CBRW02285, CBRW02298, CBRW02103,CBRW02104, CBRW02143, CBRW01578, CBRW01928, CBRW01929, CBRW01930, CBRW01933, CBRW01952, CBRW01954, CBRW02021, CBRW02044, CBRW02045, CBRW02047, CBRW02050, CBRW02052, CBRW02038, CBRW01991, CBRW02018, CBRW02028, CBRW02034, CBRW02035, CBRW02036, CBRW00982, CBRW00983, CBRW00984, CBRW00985, CBRW00986, CBRW01829, CBRW01850, CBRW01851, CBRW01855, CBRW01859, CBRW01568, CBRW01574, CBRW01108, CBRW02592, CBRW02593, CBRW02594, CBRW01078, CBRW01079, CBRW01080, CBRW01081, CBRW01082, CBRW01083, CBRW01084, CBRW01085, CBRW01086, CBRW01087, CBRW01614, CBRW01615, CBRW01617, CBRW01621, CBRW01628, CBRW01629, CBRW01637, CBRW01638, CBRW01639, CBRW01650, CBRW01663,  CBRW01202, CBRW01203, CBRW01207, CBRW01211, CBRW01217, CBRW01218, CBRW01745, CBRW01585, CBRW01593, CBRW01269, CBRW01270, CBRW01271, CBRW01272, CBRW01273, CBRW01274, CBRW01275, CBRW01276, CBRW01277, CBRW01278, CBRW01279, CBRW01280, CBRW01281, CBRW01282, CBRW01688, CBRW01734, CBRW01748, CBRW01765, CBRW01766, CBRW01773, CBRW01781, CBRW01782, CBRW01784, CBRW01785, CBRW01786, CBRW01787, CBRW01789, CBRW01790, CBRW01791, CBRW01792, CBRW01793, CBRW01938, CBRW01941, CBRW01942, CBRW01943CBRW01944 CBRW01945, CBRW01949, CBRW01956, CBRW01957, CBRW01958, CBRW02483, CBRW02484, CBRW02485, CBRW02486, CBRW02487, CBRW02490, CBRW02493, CBRW02494, CBRW02496, CBRW02497, CBRW02498, CBRW02499, CBRW02500, CBRW02501, CBRW02502, CBRW02503, CBRW02504, CBRW02511, CBRW02565, CBRW02566, CBRW02568, CBRW02590, CBRW02591, CBRW01551, CBRW01564, CBRW01565, CBRW01566, CBRW01567, CBRW01601, CBRV01842, 11489276, CBRW01571, CBRW01572, CBRW01959, CBRW01961, CBRW01710, CBRW02423, CBRW02433, CBRW02448, CBRW02548, CBRW02553, CBRW02559, CBRW02589, CBRW02595, CBRW02596, CBRW02618, CBRW02619, CBRW02622, CBRW02623, CBRW02625, CBRW02626, CBRW02646, CBRW02647, CBRW02668, CBRW02672, CBRW01285, CBRW01587, CBRW01589, CBRW01594, CBRW01596, CBRW01110, CBRW01120, CBRW01121, CBRW01138, CBRV01741, CBRW01045, CBRW01046, CBRW01047, CBRW01119, CBRW01136, CBRW01141, CBRW01713, CBRW01720, CBRW01732, CBRW01743,  CBRW01744, CBRW01756, CBRW01761, CBRW01832, CBRW01862, CBRW01885, CBRW01886, CBRW02170, CBRW02329, CBRW02330, CBRW02331, CBRW02332, CBRW02333, CBRW02334, CBRW02335, CBRW02336, CBRW02337, CBRW02338, CBRW02339, CBRW02340, CBRW02341, CBRW02342, CBRW02343, CBRW02344, CBRW02345, CBRW02346, CBRW02347, CBRW02348, CBRW02351, CBRW02352, CBRW02353, CBRW02354, CBRW02356, CBRW02357, CBRW02358, CBRW02374, CBRW02378, CBRW02379, CBRW02380, CBRW02381, CBRW02382, CBRW02383, CBRW02384, CBRW02385, CBRW02387, CBRW02388, CBRW02390, CBRW02391, CBRW02392, CBRW02393, CBRW02394, CBRW02471, CBRW02472, CBRW02473, CBRW02474, CBRW02475, CBRW02489, CBRW02491, CBRW02492, CBRW02508, CBRW02510, CBRW02515, CBRW02516, CBRW02525, CBRW02528, CBRW02533, CBRW02543, CBRW02546, CBRW02572, CBRW02597, CBRW02620, CBRW02621, CBRW02711, CBRW02746, CBRW02747, CBRW02752, CBRW02754, CBRW02755, CBRW02803, CBRW02828, CBRW02844, CBRW02850, CBRW01840, CBRW01884, CBRW01580, CBRW01848, CBRW01865, CBRW02544, 5447395, 5449444, 5449882, 5450368, 5450806, 5453175, 5456247, 5458189, 5445615-1, 5445615-2, 5445657-1, 5445657-2, 5445657-3, 5445657-4, 5445705-1, 5445705-2, 5445723-1, 5445723-2, 5445815-1, 5445815-2, 5445815-3, 5445816-1, 5445816-2, 5447746-1, 5447746-2, 5447746-3, 5447746-4, 5447746-5, 5448449-1, 5448449-2, 5454469-1, 5454469-2, 5457167-1, 5457167-10, 5457167-11, 5457167-12, 5457167-13, 5457167-14, 5457167-15, 5457167-16, 5457167-17, 5457167-18, 5457167-19, 5457167-2, 5457167-3, 5457167-4, 5457167-5, 5457167-6, 5457167-7, 5457167-8, 5457167-9, 5457943-1,  5457943-2, 5457943-3, 5457943-4, CBRW01092, CBRW01129, CBRW01131, CBRW01132, CBRW01133, CBRT00331, CBRW01236, CBRW01981,  CBRW02181, CBRW02182, CBRW02184, CBRW02187, CBRW02197, CBRW02198, CBRW02201, CBRW02203, CBRW02206, CBRW02208, 5447306, 5457519, 11017048, 11017065, 11017073, 11017091, 11017097, 11017109, 11017125, 11017186, 11017371, 11017406, 11017419, 11017424, 11017509, 11017510, 11017514, 11017670, 11017725, 11017795, 11017949, 11019263, 11017185-1, 11017185-2, 11017185-3, 11017185-4, 11017185-5, 11017488-1, 11017488-2, 11017488-3, 11017488-4, 11017488-5, BRW00964, CBRW00965, CBRW00966, CBRW00967, CBRW01216, CBRW01224,  CBRW01283, CBRW01344, CBRW01345, CBRW01346, CBRW01352, CBRW01353, CBRW01680, CBRW01861, CBRW01863, CBRW01876, CBRW01877, CBRW01887, CBRW01888, CBRW01890, CBRW02010, CBRW02011, CBRW02013, CBRW02101, CBRW02303, CBRW02313, CBRW02316, CBRW02370, CBRW02371, CBRW02373, CBRW02375, CBRW02389, CBRW02395, CBRW02396, CBRW02397, CBRW02398, CBRW02399, CBRW02400, CBRW02401, CBRW02402, CBRW02407, CBRW02408, CBRW02409, CBRW02410, CBRW02411, CBRW02412, CBRW02413, CBRW02414, CBRW02415, CBRW02416, CBRW02417, CBRW02418, CBRW02419, CBRW02426, CBRW02427, CBRW02428, CBRW02430, CBRW02450, CBRW02538, CBRW02542, CBRW02771, CBRW02776, CBRW02794, CBRW02795, CBRW02796, CBRW02797, CBRW02798, CBRW02820, CBRW01548, CBRW01556, CBRW01558, CBRW01137, CBRW01139, CBRW01140, CBRW01145, CBRW01146,  CBRW01122, CBRW01123, CBRW01124, CBRW01125, CBRW01126, CBRW01127, CBRW01128, CBRW01130, CBRU02111, CBRW01659, CBRW01391, CBRW01392, CBRW01517, CBRW01518, CBRW01519, CBRW01522, CBRW01523, CBRW01525, CBRW01527, CBRW01528, CBRW01529, CBRW01530, CBRU00192, CBRU03363, CBRW01837, CBRU02907, CBRW01198, CBRW01181, CBRW01182, CBRW01183, CBRU02631, CBRW01332, CBRW01374, CBRW01376, CBRW01377, CBRW01378, CBRW01386, CBRW01387, CBRW01388, CBRW01389, CBRW01390, CBRW01247, CBRW01427, CBRW01428, CBRV01710, CBRW01488, CBRW01489, CBRW01490, CBRW02728, CBRW02759, 6526298, 6526558, 6527101, 6529043, CBRW01205, CBRW01206, CBRW01215, CBRW01222, CBRW01223, CBRW01434, CBRW01435, CBRW01463, CBRW01467, CBRW01477, CBRW01503, CBRW01504, CBRW01616, CBRW01626, CBRW01670, CBRW01681, CBRW01683, CBRW01685, CBRW01691, CBRW01711, CBRW01714, CBRW01716, CBRW01717, CBRW01718, CBRW01719, CBRW01721, CBRW01806, CBRW01815, CBRW01816, CBRW01817, CBRW01818, CBRW01819, CBRW01822, CBRW01828, CBRW01843, CBRW01844, CBRW01845, CBRW01852, CBRW01853, CBRW01864, CBRW01870, CBRW01871, CBRW01872, CBRW01873, CBRW01874, CBRW01875, CBRW01935, CBRW01936, CBRW01939, CBRW01940, CBRW01950, CBRW01960, CBRW01966, CBRW01967, CBRW01968, CBRW01970, CBRW02137, CBRW02153, CBRW02154, CBRW02155, CBRW02156, CBRW02159, CBRW02163, CBRW02164, CBRW02167, CBRW02168, CBRW02169, CBRW02171, CBRW02172, CBRW02173, CBRW02177, CBRW02178, CBRW02188, CBRW02317, CBRW02320, CBRW02321, CBRW02322, CBRW02323, CBRW02324, CBRW02325, CBRW02326, CBRW02327, CBRW02328, CBRW00941, CBRW01444, CBRW01442, CBRW01443, CBRW01001, CBRW01002, CBRW01003, CBRW01004, CBRW01006, CBRW01007, CBRW01226, CBRW01228, CBRW01241, CBRW01230, CBRW01231, CBRW01234, CBRW01235, CBRW01237, CBRW01238, CBRW00981, CBRW00988, CBRW00989, CBRW00990, CBRW00998, CBRW00999, CBRW01117, CBRW01118, CBRW01415, CBRW01416, CBRW01417, CBRW01418, CBRW01060, CBRW01433, CBRW01436, CBRW01438, CBRW01440, CBRW01441, CBRW01395, CBRW01400, CBRW01398, CBRW01399, CBRW01173, CBRW01175, CBRW01176, CBRW01177, CBRW01178, CBRW01179, CBRW01419, CBRW01420, CBRW01421, CBRW01422, CBRW01423, CBRW01424, CBRW01425, CBRW01426, CBRW01199, CBRW01201, CBRW01379, CBRW01380, CBRW01381, CBRW01383, CBRW01384, CBRW01396, CBRW01200, CBRW01204, CBRW01618, CBRW01712, CBRW01736, CBRW01751, CBRW01759, CBRW01763, CBRW01764, CBRW01043, CBRW01050, CBRW01054, CBRW01106, CBRW01195, CBRW01196, CBRW01197, CBRW01208, CBRW01209, CBRW01213, CBRW01214, CBRW01219, CBRW01220, CBRW01225, CBRW01227, CBRW01229, CBRW01233, CBRW01239, CBRW01240, CBRW01847, CBRW01969, CBRW02003, CBRW02004, CBRW02006, CBRW02009, CBRW02012, CBRW02015, CBRW02016, CBRW02022, CBRW02027, CBRW02030, CBRW02031, CBRW02054, CBRW02057, CBRW02058, CBRW02059, CBRW02062, CBRW02111, CBRW02113, CBRW02118, CBRW00909, CBRW00910, CBRW00911, CBRW00912, CBRW00913, CBRW00915, CBRW00916,, CBRW00917, CBRW00920, CBRW00921, CBRW00922, CBRW00923, CBRW00924, CBRW00925,, CBRW00926, CBRW00927, CBRW00928, CBRW00929, CBRW00930, CBRW00931, CBRW00932, CBRW00933, CBRW00945, CBRW00946, CBRW00947, CBRW00948, CBRW00949, CBRW00950, CBRW00951, CBRW00952, CBRW00953, CBRW00954, CBRW00955, CBRW00956, CBRW00957, CBRW00958, CBRW00959, CBRW00960, CBRW01364, CBRW01365, CBRW01366, CBRW01367, CBRW01931, CBRW01445, CBRW01526, CBRW01549, CBRW01552, CBRW01598, CBRW01613, CBRW01620, CBRW01623, CBRW01627, CBRW01660, CBRW01667, CBRW01668, CBRW01245, CBRW01246, CBRW01248, CBRW01249, CBRW01250, CBRW01251, CBRW01252, CBRW01253, CBRW01254, CBRW01255, CBRW01256, CBRW01257, CBRW01258, CBRW01259, CBRW01260, CBRW01261, CBRW01262, CBRW02302, CBRW01987, CBRW01988, CBRW02005, CBRW02019, CBRW01243, CBRW01148, CBRW01150, CBRW01164, CBRW01185, CBRW01186, CBRW01187, CBRW01188, CBRW01189, CBRW01190, CBRW01191, CBRW01192, CBRW01193, CBRW01194, CBRW01550, CBRW01569, CBRW01576, CBRW01579, CBRW01597, CBRW01611, CBRW01612,, CBRW01641, CBRW01643, CBRW00997, CBRW02434, CBRW02435, CBRW02436, CBRW02437, CBRW02438, CBRW02439, CBRW02440, CBRW02441, CBRW02444, 6528877, CBRW01406, CBRW01407, CBRW01408, CBRW01409, CBRW01411, CBRW02232, CBRW02236, CBRW02238, CBRW00971, CBRW00972, CBRW00973, CBRW00974, CBRW00975, CBRW00976, CBRW00977, CBRW00978, CBRW00979, CBRW00980, CBRW01354, CBRW01473, CBRW01474, CBRW01476, CBRW01042, 6526204-1, 6526204-2, 6526204-3, CBRW0174, CBRW01184, CBRT00611 CBRW01554, CBRW01562, CBRW01575, CBRW01591, CBRW01605, CBRW01606, CBRW01607,, CBRW01635, CBRW01553 CBRW01975 CBRW01976 CBRW02527 CBRW01368 CBRW02199 CBRW02200 CBRV02046 CBRW02121 CBRW01098 CBRW01100 CBRW01101 CBRW01103 CBRW01286 CBRW01287 CBRW01487 CBRW01515 CBRW01524 CBRW02191 CBRW02207 CBRW02545 CBRW02558 CBRW01640 CBRW01653 CBRW01654 CBRW01656 CBRW01657 CBRW01664 CBRW01665 CBRW01666 CBRW02429 CBRW01242 CBRW02007 CBRW02008 CBRW01531 CBRW01532 CBRW01533 CBRW01534 CBRW01535 CBRW01536 CBRW01180 CBRW01446 CBRW01449 CBRW01450 CBRW01451 CBRW01452 CBRW01453 CBRW01454 CBRW01455 CBRW01456 CBRW01457 CBRW01458 CBRW01459 CBRW01460 CBRW01461 CBRW01462 CBRW01465 CBRW01466 CBRW01468 CBRW01469 CBRW01470 CBRW01471 CBRW01472 CBRW01475 CBRW01481 CBRW01483 CBRW01484 CBRW01973 CBRW01351 CBRW01491 CBRW01492 CBRW01493 CBRW01494 CBRW01495 CBRW01496 CBRW01497 CBRW01498 CBRW01499 CBRW01500 CBRW01501 CBRW01502 CBRW01513 CBRW01514 CBRW02202 CBRW01595 CBRW01672 CBRW01682 CBRW01686 CBRW01689 CBRW01692 CBRW01694 CBRW01695 CBRW01696 CBRW01697 CBRW01699 CBRW01708 CBRW00962 CBRW00963 CBRW00968 CBRW00969 CBRW00970 CBRW01625 CBRW01633 CBRW01636 CBRW01662 CBRW01671 CBRW01679 CBRW01698 CBRW01700 CBRW01701 CBRW01702 CBRW01703 CBRW01704 CBRW01705 CBRW01706 CBRW01707 CBRW01263 CBRW01264 CBRW01265 CBRW01266 CBRW01267 CBRW01268 CBRU02180 CBRV02754 CBRW00641 5454414 5454413-1 5454413-2 6527173-1 6527173-2 6527173-3 6527173-4 6527173-5 6527173-6 6528692-1 6528692-2 CBRV01531 CBRV01534 CBRV01535 CBRW01951 CBRW01977 CBRW01978 CBRW01985 CBRW01989 CBRW01995 CBRW01996 CBRW01997 CBRW01998 CBRW01999 CBRW02276 CBRW02277 CBRW02278 CBRW02279 CBRW02294 CBRW02295 CBRW02297 CBRW02522 CBRW02532 CBRW02664 CBRW02670 CBRW02673 CBRW02682 CBRW02683 CBRW02685 CBRW02709 CBRW02710 CBRW02715 CBRW02721 CBRW02722 CBRW02723 CBRW02729 CBRW02741 CBRW02742 CBRW02745 CBRW02751 CBRW02756 CBRW02760 CBRW02761 CBRW02767 CBRW02770 CBRW02789 CBRW02811 CBRW02827 CBRW02842 CBRW01540 CBRW01545 CBRW01642 CBRW01622 CBRW01624 CBRW01693 CBRW01728 CBRW01729 CBRW01730 CBRW01775 CBRW01776 CBRW01777 CBRW01778 CBRW01779 CBRW01780 CBRW01984 CBRW01994 CBRW02000 CBRW02001 CBRW02002 CBRW02296 CBRW01762 CBRW02189 CBRW00961 6526481-1 6526481-2 CBRW01813 CBRW02106 CBRW02119 CBRW02607 CBRW02680 CBRW02681 CBRW02724 CBRW02727 CBRW02782 CBRW02847 CBRW02848 CBRW02869 CBRW01429 CBRW01430 CBRW01431 CBRW01432 CBRW02020 CBRW02024 CBRW02029 CBRW02032 CBRW02033 CBRW01337 CBRW02116 CBRW02117 CBRW01980 CBRW02014 CBRW02017 CBRW02025 CBRW02026 CBRW02039 CBRW02040 CBRW01955 CBRW01962 CBRW01963 CBRW01979 CBRW01537 CBRW01538 CBRW01539 CBRW01541 CBRW01542 CBRW01543 CBRW02315 CBRW02319 6529674 CBRW00987 CBRW00992 CBRW00993 CBRW00994 CBRW00995 CBRW00996 CBRW01000 CBRW01005 CBRW01008 CBRW01011 CBRW01012 CBRW01013 CBRW01014 CBRW01015 CBRW01017 CBRW01025 CBRW01397 CBRW01402 CBRW01403 CBRW01404 CBRW01405 CBRW01982 CBRW01986 CBRW01990 CBRW01993 CBRW02160 CBRW02174 CBRW02175 CBRW02176 CBRW02243 CBRW01212 CBRW01221 CBRW01649 CBRW01655 CBRW01675 CBRW01676 CBRW01677 CBRW01678 CBRW01651 CBRW02258 CBRW02259 CBRW02260 CBRW02261 CBRW02262 CBRW02263 CBRW02265 CBRW02266 CBRW01557 CBRW01563 CBRW01577 CBRW01583 CBRW01590 CBRW01600 CBRW01602 CBRW01603 CBRW01610 CBRW01632 CBRW01646 CBRW01647 CBRW01648 CBRW01652 CBRW01673 CBRW01674 CBRW01363 CBRW01369 CBRW01370 CBRW01371 CBRW01372 CBRW01373 CBRW01544 CBRW01555 CBRW01599 CBRW01608 CBRW01609 CBRW02431 CBRW02432 CBRW02443 CBRW02445 CBRW02447 CBRW02547 CBRW02549 CBRW02550 CBRW02551 CBRW02552 CBRW02556 CBRW02557 CBRW02567 CBRW02570 CBRW02571 CBRW01095 CBRW01099 CBRW01288 CBRW01289 CBRW01290 CBRW01291 CBRW01296 CBRW01788 CBRW01803 CBRW01826 CBRW02554 CBRW02555 CBRW02560 CBRW02561 CBRW02644 CBRW02662 CBRW02691 CBRW02692 CBRW02708 CBRW02730 CBRW02731 CBRW02732 CBRW02733 CBRW02734 CBRW02736 CBRW02737 CBRW02738 CBRW02739 CBRW01159 CBRW01760 CBRW01811 CBRW01812 CBRW02604 CBRW01210 CBRW02299 CBRW02300 CBRW01631 CBRW01661 CBRW01687 CBRW01690 CBRW01709 CBRW01722 CBRW01723 CBRW01724 CBRW01725 CBRW01726 CBRW01731 CBRW01747 CBRW01749 CBRW01750 CBRW01752 CBRW01801 CBRW01841 CBRW01854 CBRW02041 CBRW02042 CBRW02043 CBRW00991 CBRW01009 CBRW01010 CBRW01016 CBRW01018 CBRW01026 CBRW01027 CBRW01028 CBRW01029 CBRW01030 CBRW01037 CBRW01038 CBRW01039 CBRW01040 CBRW01041 CBRW01088 CBRW01089 CBRW01090 CBRW01091 CBRW01093 CBRW01094 CBRW01292 CBRW01293 CBRW01294 CBRW01295 CBRW01297 CBRW01298 CBRW01299 CBRW01300 CBRW01301 CBRW01302 CBRW01303 CBRW01304 CBRW01305 CBRW01306 CBRW01307 CBRW01308 CBRW01309 CBRW01310 CBRW01311 CBRW01312 CBRW01313 CBRW01314 CBRW01315 CBRW01316 CBRW01317 CBRW01318 CBRW01319 CBRW01320 CBRW01321 CBRW01322 CBRW01323 CBRW01324 CBRW01325 CBRW01326 CBRW01327 CBRW01329 CBRW01330 CBRW01331 CBRW01333 CBRW01338 CBRW01727 CBRW01733 CBRW01738 CBRW01740 CBRW01769 CBRW01774 CBRW02068 CBRW02112 CBRW02349 CBRW02350 CBRW02355 CBRW02359 CBRW02360 CBRW02361 CBRW02362 CBRW02363 CBRW02364 CBRW02365 CBRW02366 CBRW02367 CBRW02368 CBRW02369 CBRW02372 CBRW02376 CBRW02377 CBRW02386 CBRW02403 CBRW02404 CBRW02446 CBRW02451 CBRW02452 CBRW02453 CBRW02454 CBRW02455 CBRW02456 CBRW02457 CBRW02458 CBRW02459 CBRW02460 CBRW02461 CBRW02462 CBRW02463 CBRW02464 CBRW02465 CBRW02466 CBRW02467 CBRW02468 CBRW02480 CBRW02481 CBRW02512 CBRW02513 CBRW02624 CBRW02628 CBRW02630 CBRW02643 CBRW02645 CBRW02649 CBRW02650 CBRW02651 CBRW02669 CBRW02671 CBRW02674 CBRW02675 CBRW02701 CBRW02703 CBRW02704 CBRW02705 CBRW02706 CBRW02712 CBRW02717 CBRW02718 CBRW02719 CBRW02720 CBRW02725 CBRW02726 CBRW02740 CBRW02743 CBRW02744 CBRW02765 CBRW02766 CBRW02768 CBRW02769 CBRW02775 CBRW02777 CBRW02778 CBRW02779 CBRW02780 CBRW02781 CBRW02783 CBRW02784 CBRW02785 CBRW02790 CBRW02791 CBRW02792 CBRW02793 CBRW02800 CBRW02801 CBRW02802 CBRW02804 CBRW02806 CBRW02809 CBRW02812 CBRW02813 CBRW02814 CBRW02815 CBRW02816 CBRW02817 CBRW02818 CBRW02819 CBRW02821 CBRW02822 CBRW02823 CBRW02824, CBRW02830, CBRW02831, CBRW02832, CBRW02833, CBRW02835, CBRW02836, CBRW02837, CBRW02838, CBRW02839, CBRW02843, CBRW02849, CBRW02851, CBRW02852, CBRW02853, CBRW02854, CBRW02855, CBRW02856, CBRW02857, CBRW02858, CBRW02859, CBRW02860, CBRW02861, CBRW02862, CBRW02868, CBRW02870, CBRW02871, CBRW02872, CBRW02874, CBRW02878, CBRW02880, CBRW02881, CBRW02882, CBRW02883, CBRW02884, CBRW02885, CBRW02886, CBRW02887, CBRW02888, CBRW02889, CBRW02890, CBRW02891, CBRW02892, CBRW02893, CBRW02895, CBRW02896, CBRW02902, CBRW02903, CBRW02907, CBRW02909, CBRW03005, CBRW03006, CBRW03007, CBRW03013, CBRW03014, CBRW01478, CBRW01479, CBRW01684, CBRW01737, CBRW01739, CBRW01142, CBRW01143, CBRW01144, CBRW01334, CBRW01335, CBRW01336, CBRW01339, CBRW01340, CBRW01341, CBRW01342, CBRW01343, CBRW01348, CBRW01560, CBRW01561, CBRW01581, CBRW01584, CBRW01592, CBRW01953, CBRW02318, CBRW01096, CBRW01097, CBRW01102, CBRW01104, CBRW01105, CBRW01107, CBRW01109, CBRW01111, CBRW01113, CBRW01114, CBRW01115, CBRW01116, CBRW01134, CBRW01135, CBRW01153, CBRW01154, CBRW01160, CBRW01161, CBRW01162, CBRW01163, CBRW01165, CBRW01166, CBRW01167, CBRW01168, CBRW01169, CBRW01170, CBRW01171, CBRW01172, CBRW01174, CBRW01349, CBRW01350, CBRW01355, CBRW01356, CBRW01357, CBRW01358, CBRW01359, CBRW01360, CBRW01361, CBRW01362, CBRW01382, CBRW01385, CBRW01393, CBRW01394, CBRW01480, CBRW01482, CBRW01485, CBRW01486, CBRW01505, CBRW01506, CBRW01507, CBRW01508, CBRW01509, CBRW01510, CBRW01511, CBRW01512, CBRW01516, CBRW01520, CBRW01521, CBRW02132, CBRW02133, CBRW02134, CBRW02135, CBRW02136, CBRW02138, CBRW02139, CBRW02140, CBRW02141, CBRW02142, CBRW02148, CBRW02149, CBRW02150, CBRW02151, CBRW02152, CBRW02157, CBRW02158, CBRW02161, CBRW02162, CBRW02165, CBRW02166, CBRW02179, CBRW02180, CBRW02183, CBRW02185, CBRW02186, CBRW02190, CBRW02192, CBRW02193, CBRW02194, CBRW02195, CBRW02196, CBRW02204, CBRW02205, CBRW02209, CBRW02210, CBRW02211, CBRW02212, CBRW02213, CBRW02214, CBRW02215, CBRW02217, CBRW02218, CBRW02219, CBRW02220, CBRW02221, CBRW02222, CBRW02223, CBRW02224, CBRW02225, CBRW02226, CBRW02227, CBRW02228, CBRW02229, CBRW02230 CBRW02231, CBRW02233, CBRW02234, CBRW02235, CBRW02237, CBRW02239, CBRW02240, CBRW02241, CBRW02242, CBRW02244, CBRW02245, CBRW02246, CBRW02247, CBRW02248, CBRW02250, CBRW02251, CBRW02252, CBRW02253, CBRW02254, CBRW02255, CBRW02256, CBRW02257, CBRW02264, CBRW02267, CBRW02268, CBRW02269, CBRW02270, CBRW02271, CBRW02272, CBRW02273, CBRW02274, CBRW02275, CBRW02280, CBRW02281, CBRW02282, CBRW02283, CBRW02284, CBRW02286, CBRW02288, CBRW02289, CBRW02290, CBRW02291, CBRW02292, CBRW02293, CBRW02405, CBRW02406, CBRW02569, CBRW02663, CBRW02665, CBRW02666, CBRW02667,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, GA, ID, IL, IN, MS, NC, NJ, NK, NV, OH, OK, RI, TX, and WI., and to the countries of : Albania, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, El Salvador, Estonia, Ethiopia, Egypt, Finland, France, Germany, Ghana, Hungary, India, Indonesia, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Russia, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam
  • Product Description
    CARESCAPE R860 ventilators with software version 10SP05 || Product Usage: || The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within facility transport, and should only be used under the orders of a clinician.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Datex-Ohmeda, Inc., 3030 Ohmeda Dr, Madison WI 53718-6704
  • Manufacturer Parent Company (2017)
  • Source
    USFDA