EVair air compressor, model numbers: M1230849 and M1230847
Publicado el 7 de febrero de 2024 · Inicio del retiro: 29 de diciembre de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Datex-Ohmeda, Inc.
- Distribuidor
- Worldwide
- Lote
- 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, CBRV01141, CBRV01140, CBRV01150, CBRV01148, CBRV01143, CBRV01145, CBRV01155, CBRV01144, CBRV01153, CBRV01158, CBRV01123, CBRW00863, CBRW00843, CBRW00870, CBRW00869, CBRW00860, CBRW00866, CBRW00867, CBRW00865, CBRW00714, CBRW00871, CBRW00880, CBRW00881, CBRV02069, CBRV02068, CBRV02066, CBRV02070, CBRV02067, CBRV02060, CBRV02064, CBRV02030, CBRV02368, CBRU03460, CBRU03462, CBRY01193, CBRX01836, CBRX01310, CBRV02156, CBRX01285, CBRY01909, CBRV02055, CBRV02057, CBRV02027, CBRX04460, CBRX04475, CBRW00635, CBRW00627, CBRW00628, CBRV02101, CBRV02179, CBRX01304, CBRX01303, CBRT00370, CBRU02122, CBRU02121, CBRU02123, CBRU02130, CBRU02127, CBRU02125, CBRU02120, CBRU02134, CBRV02051, CBRV02053, CBRV02022, CBRV02099, CBRV02125, CBRV02116, CBRV02178, CBRV02158, CBRV02174, CBRY01370, CBRV02021, CBRU02129, CBRV02118, CBRV02190, CBRV02189, CBRV02149, CBRV02154, CBRV02123, CBRX01485, CBRX01486, CBRX01481, CBRX01488, CBRX01501, CBRX01505, CBRW00765, CBRW00766, CBRW00769, CBRW00767, CBRW00768, CBRW00763, CBRW00758, CBRW00759, CBRW00764, CBRW00761, CBRW00773, CBRW00771, CBRW00760, CBRV03102, CBRW00757, CBRY02728, CBRY02731, CBRY02733, CBRX03037, CBRV02590, CBRV03035, CBRU02475, CBRU02473, CBRU02467, CBRU02480, CBRU02485, CBRT00101, CBRV02163, CBRV02548, CBRV02028, CBRV02074, CBRV02079, CBRV02078, CBRV02087, CBRW00859, CBRU02477, CBRV02230, CBRV02232, CBRV02250, CBRV02249, CBRV02248, CBRV02157, CBRV02307, CBRV02304, CBRW02661, CBRX03503, CBRV01536, CBRV03011, CBRY01767, CBRU02126, CBRX01183, CBRX01187, CBRX01171, CBRX01192, CBRX01223, CBRX01220, CBRX01158, CBRX01154, CBRX01842, CBRX01851, CBRX01835, CBRW00633, CBRW00634, CBRW00624, CBRV02029, CBRV02058, CBRY02729, CBRY02734, CBRV00329, CBRV02714, CBRV02700, CBRV02473, CBRV02627, CBRV02804, CBRV02825, CBRV02819, CBRV02630, CBRV02803, CBRV02820, CBRV02812, CBRV02689, CBRV02460, CBRV02813, CBRV02457, CBRV02625, CBRY00246, CBRY00241, CBRY00239, CBRY00240, CBRY00245, CBRY00228, CBRV03040, CBRV03044, CBRY00203, CBRV02247, CBRV02475, CBRV02470, CBRV02621, CBRV02624, CBRV02623, CBRV02620, CBRV02595, CBRY02632, CBRY00967, CBRY01013, CBRY01024, CBRX03654, CBRW03090, CBRW03079, CBRW03089, CBRW03085, CBRW03083, CBRW03084, CBRW03077, CBRW03078, CBRW03080, CBRW03081, CBRU02513, CBRU02512, CBRU02518, CBRU02517, CBRV00583, CBRV00573, CBRV00568, CBRV00554, CBRU02128, CBRU02114, CBRU02124, CBRU02113, CBRU02110, CBRU02112, CBRU02135, CBRU02143, CBRU02455, CBRU02725, CBRU02722, CBRU02724, CBRU02726, CBRU02728, CBRU02729, CBRV02039, CBRV02020, CBRV021
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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