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;
Published February 7, 2024 · Recall initiated: December 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datex-Ohmeda, Inc.
- Distributor
- Worldwide
- Lot
- 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, GE
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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