EvAir Cprsr Kit Upgrade: a) Diss/Cee 7/7 230V 50/60 HZ recalled

Yes. Datex-Ohmeda recalled EvAir Cprsr Kit Upgrade: a) Diss/Cee 7/7 230V 50/60 HZ on 29 Dec 2023. The recall is Class I and its status is Ongoing. Recall number Z-0776-2024.

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, 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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

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Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.