Datex-Ohmeda, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0776-2024)

EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;

Class I

GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.

a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers: GEB08691, GEB08778, GEB08726, GEB08791, GEB08782, GEB08780, GEB08651, GEB08694, GEB08776, GEA05881, GEA05877, GEA05883, GEA05882, GEA05880, GEA04101, GEA05302, GEA04586, GEA04621, GEA05372, GEA05304, GEA04587, GEA04556, GEA05369, GEA04588, GEA04620, GEA04098, GEA05303, GEA05301, GEA04618, GEA04619, GEA04099, GEA04589, GEA04100, GEB08768, GEA04550, GEA06057, GEA06119, GEA06116, GEA07318, GEA06709, GEA07513, GEA07155, GEA07162, GEA07434, GEA07428, GEA07433, GEA07511, GEA07431, GEA07568, GEA07528, GEA07152, GEA03205, GEA03202, GEA03204, GEA03203, GEA06055, GEA06117, GEA04802, GEA06118, GEA06056, GEA04553, GEA04800, GEA04803, GEA04801, GEA07822, GEA07842, GEA07840, GEA07839, GEA07851, GEA07804, GEA07901, GE021663, GE021666, GEA03006, GEA03008, GEA03007, GEA03005; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; UDI/DI *TBP* , Serial Numbers: GEA07877, GEA07866, GEA08370, GEA08369, GEA07893, GEA07892, GEB08822, GEB08809, GEB08827, GEB08820, GEB08813, GEA06781, GEA06778, GEB08835, GEB08817, GEA07895, GEA07859, GEA07896, GEA07861, GEB08821; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers: GEA06054, GEB08069, GEB07991, GEB07965, GEB08171, GEB08276, GEB07412, GEB07440, GEB03790, GEB08164, GEB07396, GEB08242, GEB08172, GEB08243, GEB08245, GEB08239, GE021229, GE021230, GEA04266, GEA04269, GEA04265, GEA04264, GEA04263, GEB09817, GEB09804, GEB09808, GEB09855, GEB09863, GEB09719, GEB09853, GEB09823, GEB09856, GEB09822, GEB08785, GEB08792, GEB08781; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers: GEB09437, GEB09803, GEB09824, GEB09819, GEB09402, GEB09391, GEA07666, GEA07643, GEA07663, GEA07857, GEA07914, GEB09401, GEB09932, GEA07904, GEA07902, GEA07610, GEA07856, GEA07652, GEA07711, GEA07720, GEA07665, GEA07609, GEA07634, GEA07599, GEA07577, GEA07611, GEA07633, GEA07655, GEA07845, GEA07617, GEA07607, GEB09319, GEB09827, GEB09829, GEB09821, GEB09825, GEB09828, GEB09801, GEB09806, GEB09398, GEB09452, GEB09952, GEB09947, GEA07625, GEA07710, GEA07830, GEA07792, GEA07382, GEA07829, GEA07445, GEA07658, GEA07442, GEA07653, GEA07713, GEA03057, GEA03058, GEA03059, GEA03247, GEA03246, GEA03029, GEA03032, GEA03030, GEA03060, GEA03031, GEB09453, GEB09811, GEA07834, GEB08137, GEA03520, GEA03522, GEA03518, GEB09440, GEB09436, GEB09861, GEB09837, GEB09849, GEB08155, GEB08162, GEB09314, GEA03870, GEA03871, GEA03872, GEA03873, GEA07903, GEA07571, GEA07809, GEB09499, GEB09447, GEB09491, GEB09418, GEB09500, GEB09431, GEB09371, GEB09376, GEB09339, GEB09393, GEB09334, GEB09779, GEB09854, GEB09782, GEB09831, GEB09830, GEB09948, GEB09917, GEB09847, GEB09945, GEA07656, GEA07787, GEA03558, GEA03544, GEA03535, GEA03532, GEA03557, GEA07618, GEA07826, GEA07426, GEA07444, GEA07812, GEA03527, GEA03529, GEA03521, GEA03528, GEB09422, GEB09427, GEB09430, GEA03559, GEA03533, GEA03534, GEA03501, GEA03500, GEA03502, GEA03503, GEA03530, GEA07608, GEA07591, GE020660, GE020657, GEA07576, GEA07578, GEA07569, GEB08738, GEB08737, GEB08702, GEB09317, GEB09318, GEB09394, GEB09451, GEB09407; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers: GEB08741, GEB08755, GEB08690, GEB08704, GEB08697, GEB08744, GEB08747, GEB08722, GEB08648, GEB08709, GEB08669, GEB08896, GEB08905, GEB08729, GEB08902, GEB08903, GEB08899, GEB08897, GEB08898, GEB08893, GEB08901, GEB08908, GEB08907, GEB08793, GEB08798, GEB08789, GEB08895, GEB08742, GEB08894, GEB08788, GEB08644, GEB08761, GEB08685, GEB08787, GEB08770, GEB08667, GEB08665, GEB08757, GEB08765, GEB08777, GEB08687, GEB08666, GEB08784, GEB08745, GEB08753, GEB08713, GEB08752, GEB08711, GEB08695, GEB08717, GEB08700, GEB08714, GEB08774, GEB08775, GEB08710, GEB08763, GEB08649, GEB08689, GEB08758, GEB08764, GEB08716, GEB08751, GEB08725, GEB08767, GEB08944, GEB08911, GEB08912, GEB09026, GEB08985, GEB09003, GEB09025, GEB08937, GEB08913, GEB09005, GEB09011, GEB09017, GEB09004, GEB09027, GEB09006, GEB08915, GEA04108, GEA03972, GEA04945, GEA04356, GEA04109, GEA03971, GEA04343, GEA04120, GEA04122, GEA04001, GEA04321, GEA04954, GEA04106, GEA03999, GEA04319, GEA04000, GEA04955, GEA04046, GEA05002, GEA03973, GEA04965, GEA04953, GEA04346, GEA04049, GEA04967, GEA04119, GEA03998, GEA04048, GEA04964, GEA04966, GEA05001, GEA04322, GEA04357, GEA04237, GEA04235, GEA04047, GEA04107, GEA04944, GEA05003, GEA03970, GEA04238, GEA04946, GEA04121, GEA04355, GEA05004, GEA04344, GEA04358, GEA04345, GEA04952, GEA03342, GEA03345, GEA03556, GEA03514, GEA03538, GEA03166, GEA03188, GEA03159, GEA03554, GEA03542, GEA03541, GEA03170, GEA03268, GEA03168, GEA03186, GEA07644, GEA07359, GEA07642, GEA07360, GEA07734, GEA07744, GEA07715, GEA07636, GEA07381, GE021410, GE021526, GE021574, GEA03344, GEA03321, GEA03540, GEA03079, GEA03549, GEA03080, GEA03160, GEA03158, GEA03173, GEA03069, GEA03266, GEA03269, GEA03516, GEA03508, GEA03531, GEA03513, GEA03543, GEA03545, GEA03072, GEA03517, GEA03167, GEA03077, GEA03078, GEA03546, GEA03171, GEA03512, GEA03172, GEA03070, GEA03515, GEA03267, GEA03539, GEA03519, GEA03189, GEA03555, GEA03161, GEA03537, GEA03169, GEA03071, GEA03187, GEA06225, GEA07632, GEA07732, GEA07846, GEA07843, GEA07721, GEA07735, GEA07386, GEA07424, GEA07353, GEA07377, GEA07378, GEA07333, GEA07337, GEA07387, GEA07731, GEA07745, GEA07953, GEA07954, GEA07968, GEA07977, GEA07943, GEA07942, GEA07941, GEA07940, GEA07956, GEA07967, GEA08181, GEA06908, GEA08291, GEA07035, GEA06989, GEA08272, GEA06936, GEA08166, GEA07105, GEA06862, GEA07096, GEA07335, GEA07336, GEA07385, GEA08021, GEA07227, GEA08025, GEA06876, GEA06867, GEA07814, GEA07799, GEA07816, GEA08160, GEA08169, GEA07976, GEA08292, GEA08284, GEA07013, GEA07955, GEA07341, GEA07395, GEA07345, GEA07170, GEA07803, GEA07000, GEA07005, GEA07223, GEA08190, GEA08168, GEA08170, GEA08179, GEA07988, GEA07983, GEA07530, GEA08075, GEA08138, GEA08224, GEA08037, GEA08232, GEA07081, GEA06891, GEA08135, GEA08238, GEA08146, GEA08029, GEA07985, GEA08080, GEA08086, GEA07077, GEA08038, GEA08264, GEA08303, GEA08100, GEA07984, GEA08306, GEA08235, GEA08028, GEA08136, GEA07978, GEA07949, GEA07972, GEA07950, GEA07995, GEA07993, GEA07979, GEA07973, GEA07980, GEA07975, GEA07974, GEA07951, GEA07952, GEA07970, GEA07964, GEB08304, GEB08202, GEB08215, GEB08158, GEB08302, GEB08213, GEB08218, GEB08305, GEB08294, GEB08201, GEB08203, GEB08274, GEB08193, GEB08196, GEA03343, GEB09424, GEB09423, GEB09421, GEB09490, GEB09392, GEB09488, GEB09410, GEB09406, GEB09403, GEB09957, GEB09955, GEB08112, GEB07944, GEB08786, GEB09016, GEB08676, GEB08967, GEB09032, GEB09114, GEB09049, GEB09033, GEB09112, GEB09105, GEA03116, GEA06570, GEA06607, GEA06583, GEA06656, GEA06639, GEA06625, GEA06638, GEA06623, GEA06637, GEA06568, GEA06582, GEA06587, GEA06611, GEA06588, GEA06613, GEA06601, GEA06640, GEA06617, GEA06612, GEA06615, GEA06606, GEA06616, GEA06680, GEA06664, GEA06605, GEA06663, GEA06565, GEA06574, GEA06629, GEA06635, GEA06603, GEA06621, GEA07137, GEA06851, GEA07031, GEA03754, GEA04202, GEA03741, GEA06622, GEA06618, GEA06614, GEA06631, GEA03738, GEA03739, GEA03755, GEA03740, GEA03756, GEA04201, GEA03757, GEA06580, GEA06585, GEA06597, GEA06595, GEA07039, GEA07053, GEA07034, GEA07108, GEA07059, GEA07060, GEA07038, GEA07078, GEA07097, GEA07063, GEA07036, GEA07052, GEA07042, GEA07051, GEA07062, GEA07050, GEA07098, GE021415, GE021413, GE021412, GE021414, GEA06626, GEA06633, GE020089, GEA07581, GEA07593, GEA07549, GEA07595, GEA07586, GEA07548, GEA07537, GEA07565, GEA07550, GEA07559, GEA07545, GEA07561, GEA07555, GEA07584, GEA07551, GEA07815, GEA07368, GEA07417, GEA07802, GEA07354, GEA07817, GEA07365, GEA08001, GEA07819, GEA07797, GEA06963, GEA06975, GEA07510, GEA07515, GEA03284, GEA03283, GEA05278, GEA05261, GEA05232, GEA05264, GEA05262, GEA05231, GEA05277, GEA05263, GEA05279, GEA05280, GEA07589, GEA07587, GEA07567, GEA07592, GEA07588, GEA07583, GEA07594, GEA07585, GEA07529, GEA07557, GEA07392, GEA07393, GEA06945, GEA07021, GEA06948, GEA07003, GEA04058, GEA04320, GEB08748, GEB08735, GEB08176, GEA04060, GE021652, GE021651, GE021653, GE021650, GEB09428, GEA04059, GEA04061, GEA04200, GEA06959, GEA06688, GEA06992, GEA06958, GEA06998, GEA06947, GEA03776, GEA03777, GEA03801, GEA03798, GEA03796, GEA04515, GEA03775, GEA04199, GEA03795, GEA04442, GEA03774, GEA04514, GEA06592, GEA06600, GEA06666, GEA06604, GEA06575, GEA06596, GEA06658, GEA06659, GEA06660, GEA06722, GEA07176, GEA07201, GEA07191, GEA07242, GEA07177, GEA07228, GEA07233, GEA07225, GEA07224, GEA04268, GEA04267, GEA04517, GEA03770, GEA04225, GEA03800, GEA03799, GEA03797, GEA03794, GEA04224, GEA04819, GEA04832, GEA04892, GEA04896, GEA04895, GEA04833, GEA04897, GEA04893, GEA04894, GEA06584, GEA06367, GEA06444, GEA06329, GEA06360, GEA06338, GEA06391, GEA06376, GEA06457, GEA06387, GEA06369, GEA06453, GEA06398, GEA06378, GEA06327, GEA06452, GEA06399, GEA06245, GEA06242, GEA06230, GEA06237, GEA06254, GEA04205, GEA06256, GEA04519, GEA04518, GEA06248, GEA06222, GEA04206, GEA06396, GEA06333, GEA06393, GEA06353, GEA06875, GEA06898, GEA06897, GEA06949, GEA06993, GEA06906, GEA06871, GEA06848, GEA06877, GEA06843, GEA06852, GEA06873, GEA06928, GEA06929, GEA06899, GEA06850, GEA06912, GEA06886, GEA06892, GEA04439, GEA07016, GEA07015, GEA07020, GEA07018, GEA07017, GEA07002, GEA04236, GEA05876, GEA04226, GEA03773, GEA04223, GEA03772, GEA03771, GEA04841, GEA05448, GEA06210, GEA04843, GEA04842, GEA05426, GEA05428, GEA05404, GEA06204, GEA05446, GEA05427, GEA05403, GEA05424, GEA05925, GEA05926, GEA05927, GEA05402, GEA05445, GEA04836, GEA04821, GEA04839, GEA04838, GEA04840, GEA05401, GEA05425, GEA06209, GEA04822, GEA04837, GEA04823, GEA05924, GEA06197, GEA05447, GEA04820, GEA04551, GEA04516, GEA07009, GEA04827, GEA04899, GEA04818, GEA04816, GEA04817, GEA04824, GEA04834, GEA04835, GEA04825, GEA04826, GEA04898, GEA06524, GEA06493, GEA06408, GEA06557, GEA06491, GEA06488, GEA06546, GEA06551, GEA06558, GEA06538, GEA06556, GEA06530, GEA06401, GEA06404, GEA06409, GEA04475, GEA04547, GEA04549, GEA06260, GEA04477, GEA04255, GEA04158, GEA04143, GEA04207, GEA04146, GEA04208, GEA04145, GEA06244, GEA06529, GEA06494, GEA04257, GEA04478, GEA06512, GEA04258, GEA04144, GEA04157, GEA04155, GEA04546, GEA04196, GEA04476, GEA04548, GEA04156, GEA04209, GEA04198, GEA04210, GEA04195, GEA04197, GEA06559, GEA06545, GEA06403, GEA06619, GEA06382, GEA06636, GEA06624, GEA06400, GEA06411, GEA06388, GEA06368, GEA06381, GEA06405, GEA06370, GEA06397, GEA06383, GEA06620, GEA06931, GEA06395, GEA06366, GEA06407, GEA06365, GEA06392, GEA06930, GEA05655, GEA05658, GEA05870, GEA05869, GEA05878, GEA05665, GEA05666, GEA05879, GEA05871, GEA05657, GEA05656, GEA05868, GEA04440, GEA06872, GEA05467, GEA05468, GEA05466, GEA05457, GEA05431, GEA06842, GEA06926, GEA06834, GEA06924, GEA06881, GEA06927, GEA06847, GEA06870, GEA06844, GEA06921, GEA06894, GEA06868, GEA06882, GEA06859, GEA06849, GEA06880, GEA06845, GEA06846, GEA06883, GEA06853, GEA06919, GEA06925, GEA05664, GEA05663, GEA04521, GEA04203, GEA04204, GEA04470, GEA04468, GEA04520, GEA04469, GEA04467, GEA05509, GEA05458, GEA05465, GEA05430, GEA05429, GEA05420, GEA05419, GEA05417, GEA05418, GEA05510, GEA05459, GEA05460, GEA05508, GEA05507, GEA05432, GEA06910, GEA06920, GEA06858, GEA06923, GEA06373, GEA06355, GEA06363, GEA06364, GEA06379, GEA06349, GEA06417, GEA06425, GEA06432, GEA06911, GEA06857, GEA06922, GEA06426, GEA04441, GEA05634, GEA04632, GEA04633, GEA05631, GEA04631, GEA04552, GEA05633, GEA04630, GEA05632, GEA07235, GEA07186, GEA07218, GEA07217, GEA07187, GEA05164, GEA05422, GEA05163, GEA05162, GEA05421, GEA05161, GEA05423, GEA06223, GE021276, GE021257, GE021207, GE021206, GE021266, GE021205, GE021256, GE021259, GE021208, GE021267, GE021204, GE021210, GE021279, GE021278, GE021211, GE021265, GE021264, GE021209, GE021277, GE021258, GEB08174, GEA03231, GEA03138, GEA03139, GEA03037, GEA03018, GEA03017, GEA03375, GEA03376, GEA03242, GEA03243, GEA03254, GEA03257, GEA03245, GEA03355, GEA03386, GEA03244, GEA03385, GEA03335, GEA03334, GE020896, GE021060, GE020895, GE021074, GE021073, GE021075, GE020893, GE021063, GE020829, GE020831, GE021130, GE021129, GE021128, GE021107, GE020830, GE020832, GE021104, GE021131, GE021186, GE021037, GE021038, GE021185, GE021191, GE021188, GE021189, GE021190, GE021187, GE021522, GE021520, GE021521, GE021519, GE021480, GEA03052, GEA03049, GEA03050, GEA03194, GEA03201, GEA03198, GEA03195, GEA03200, GEA03196, GEA03197, GEA03112, GEA03140, GEA03111, GEA03141, GEA03113, GEA03110, GEA03118, GEA03119, GEA03121, GEA03286, GEA03365, GEA03341, GEA03366, GEA03352, GEA03367, GEA03377, GEA03363, GEA03364, GEA03354, GEA03357, GEA03356, GEA03340, GEA03353, GEA03338, GEA03383, GEA03362, GEA03221, GEA03336, GEA03039, GEA03256, GEA03040, GEA03378, GEA03339, GEA03337, GEA03220, GEA03351, GEA03038, GEA03384, GEA03350, GEA03020, GEA03255, GEA07800, GEA07541, GEA08295, GEA07544, GEA08297, GEA07214, GEA07935, GEA07937, GEA08300, GEA08210, GEA07158, GEA07934, GEA07932, GEA07494, GEA08212, GEA08134, GEA08065, GEA08052, GEA08129, GEA08014, GEA08053, GEA07939, GEA06968, GEA07931, GEA06754, GEA07026, GEA08207, GEA08051, GEA08018, GEA08016, GEA07929, GEA08299, GEA07936, GEA08211, GEA07971, GEA08147, GEA08013, GEA08027, GEA08024, GEA08097, GEA08096, GEA08248, GEA08253, GEA08094, GEA07908, GEA08089, GEA08251, GEA08109, GEA08250, GEA08090, GEA08122, GEA03051

Worldwide

Voluntary: Firm initiated