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.
Reason for recall: 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. Distribution: Worldwide Quantity: 4032 units Lot/code info: UDI/DI 010084068210234621, Serial Numbers: CBRW00622, CBRW00639, CBRW00630, CBRW00643, CBRW00625, CBRW00623, CBRX04576, CBRX04581, CBRX04579, CBRX04577, CBRX04578, CBRY00721, CBRY00708, CBRY00706, CBRY00688, CBRY00278, CBRY02044, CBRY02051, CBRY02043, CBRY02052, CBRY02049, CBRY02722, CBRY02712, CBRY02715, CBRY02717, CBRY02719, CBRY02711, CBRY02714, CBRY02718, CBRY02713, CBRY02686, CBRV02040, CBRV02077, CBRV02076, CBRV02075, CBRV02056, CBRV02080, CBRV02084, CBRV02097, CBRU02522, CBRU02523, CBRU03349, CBRV00125, CBRV00339, CBRV02328, CBRV02329, CBRV02331, CBRV02385, CBRW00782, CBRW00780, CBRW00781, CBRW00784, CBRX01783, CBRX01777, CBRX01775, CBRX01776, CBRV02062, CBRV02065, CBRW00685, CBRW00682, CBRW00687, CBRW00688, CBRW00680, CBRW00681, CBRW00683, CBRW00684, CBRW00674, CBRW00677, CBRW00679, CBRW00692, CBRW00690, CBRW00691, CBRY02730, CBRY02720, CBRY02736, CBRW00637, CBRW00636, CBRW00632, CBRW00629, CBRW00631, CBRX04524, CBRX04527, CBRX04526, CBRV02199, CBRV02072, CBRV02073, CBRV02071, CBRV02035, CBRW00546, CBRW00551, CBRW00540, CBRW00572, CBRW00570, CBRW00571, CBRW00564, CBRW00561, CBRW00554, CBRW00555, CBRW00568, CBRW00405, CBRW00425, CBRW00408, CBRW00410, CBRW00542, CBRW00537, CBRW00536, CBRW00583, CBRW00556, CBRW00581, CBRW00552, CBRW00548, CBRW00545, CBRW00539, CBRW00569, CBRW00573, CBRW00557, CBRW00553, CBRW00538, CBRW00579, CBRW00547, CBRW00582, CBRW00567, CBRW00566, CBRW00596, CBRW00450, CBRW00513, CBRW00456, CBRW00483, CBRV01149, CBRV01146, CBRV01147, CBRV01142, CBRV0
Official record: FDA (Device enforcement) ↗
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