Reported Jun 27, 2018 · Terminated

CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to…

Datex-Ohmeda, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Datex-Ohmeda, Inc. · 3030 Ohmeda Dr · Madison, WI · 53718-6704

Is this the product you have?

  • CARESCAPE R860 ventilators with
  • software version 10SP05 Product UsageThe 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
Lot codes and dates
  • 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, CBRW02616, ,CBRW02421, 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, CBRW01943, ,CBRW01944 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,

    573 of 573 codes

    • 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
    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,
Amount recalled
349 (US) + 2,051 (OUS)

Where it was sold

Why it was recalled

Potential for the display processor to experience an unexpected failure.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 29, 2021 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.