Exact FDA event identifier

Event 93715

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 29, 2023
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Datex-Ohmeda, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

EVair air compressor, model numbers: M1230849 and M1230847

Z-0774-2024

Recall number: Z-0774-2024
Initiated: December 29, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Datex-Ohmeda, Inc.
Quantity: 4032 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 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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, CBRV02188, CBRV02173, CBRV02117, CBRV02587, CBRV02583, CBRV02584, CBRV02578, CBRV02542, CBRV02540, CBRV02568, CBRV02563, CBRV02562, CBRV02570, CBRV02569, CBRV02585, CBRV02571, CBRV02579, CBRW00796, CBRX01246, CBRX01248, CBRX01250, CBRX01286, CBRX01309, CBRX01305, CBRX01321, CBRX01300, CBRX01302, CBRX01307, CBRX01247, CBRX01319, CBRX01317, CBRX01296, CBRX01316, CBRX01207, CBRX03039, CBRX03003, CBRX03659, CBRY00363, CBRY01147, CBRY01137, CBRY01186, CBRY01192, CBRY01302, CBRY01303, CBRY01372, CBRY01369, CBRY01373, CBRY01376, CBRY01304, CBRY01371, CBRY01282, CBRY02057, CBRU02117, CBRV02109, CBRV02561, CBRV03048, CBRY01195, CBRV00884, CBRV00881, CBRV00880, CBRU00857, CBRU00865, CBRV02588, CBRY00465, CBRY00467, CBRY00343, CBRY00325, CBRY00466, CBRV00260, CBRV00262, CBRV00263, CBRV00259, CBRY00463, CBRU00223, CBRU00222, CBRU00227, CBRU00226, CBRU00228, CBRY00461, CBRW02797, CBRV00261, CBRV00222, CBRY00473, WBRB00413, WBRB01238, WBRB01239, WBRB01235, WBRB01237, WBRB01236, CBRV00642, CBRX03781, CBRX03778, CBRX03789, CBRX03787, CBRX03786, CBRV01656, CBRV01661, CBRV01657, CBRV01655, CBRV01660, CBRV01659, CBRV01658, CBRV01638, CBRV01666, CBRV01664, CBRV01646, CBRV01667, CBRT00297, CBRT00309, CBRT00306, CBRT00308, CBRT00307, CBRU00242, CBRU00244, CBRU00243, CBRU00241, CBRU00245, CBRU00249, CBRU00240, CBRU00239, CBRU00251, CBRU00258, CBRU00252, CBRU00255, CBRU00246, CBRU00250, CBRU00248, CBRU00247, CBRU00265, CBRU00266, CBRU00814, CBRU00811, CBRU00812, CBRU00810, CBRU00813, CBRV01716, CBRV01719, CBRV02372, CBRV02449, CBRV02442, CBRW03518, CBRX03924, CBRX03922, CBRX03925, CBRX03927, CBRY00991, CBRY02085, CBRY02086, CBRY02853, CBRW03527, CBRW03522, CBRW03523, CBRW03524, CBRW03526, CBRX03921, CBRX03926, CBRX03923, CBRX03920, CBRY02087, CBRY02194, CBRY02852, CBRY02864, CBRY02846, CBRU00555, CBRW00836, CBRW00839, CBRW02532, CBRW02522, CBRX01378, CBRU00171, CBRU00616, CBRY03725, CBRV03117, CBRU00172, CBRU00554, CBRU00552, CBRU00541, CBRU00572, CBRU00568, CBRU00571, CBRU00570, CBRU00569, CBRU00562, CBRU00566, CBRU00540, CBRU00559, CBRU00551, CBRU00523, CBRU00498, CBRU00512, CBRU00553, CBRU00561, CBRU00517, CBRU00565, CBRU00563, CBRU00567, CBRU00509, CBRU00550, CBRU00522, CBRU00605, CBRU00603, CBRU00602, CBRU00621, CBRU00574, CBRU00604, CBRU00600, CBRU00622, CBRU00560, CBRU00606, CBRU00578, CBRU00580, CBRU00577, CBRU00579, CBRU00619, CBRU00596, CBRU00598, CBRU00597, CBRU00594, CBRU00595, CBRU00575, CBRU00614, CBRU00601, CBRU00620, CBRU00593, CBRU00613, CBRU00608, CBRU00607, CBRU00581, CBRU00624, CBRU00599, CBRU00573, CBRW02249, CBRU00173, WBRZ01955, WBRZ01954, WBRZ01953, WBRZ01959, WBRZ01956, WBRZ01957, WBRZ01951, WBRZ01960, WBRZ01949, WBRZ01947, WBRZ01952, WBRZ01948, WBRZ01950, WBRZ01946, WBRZ01963, WBRZ01964, WBRZ01962, WBRZ01961, WBRZ01965, WBRZ01958, CBRU00169, CBRU00168, CBRY02116, CBRW02049, CBRY00458, CBRX04316, CBRY00732, CBRX00104, CBRY00299, CBRY00216, CBRW02055, CBRW02056, CBRY02073, CBRW01742, CBRY02567, CBRX02758, CBRY00309, CBRY02594, CBRW02048, WBRC80905, WBRZ00008, CBRY00474, CBRW00848, CBRW02046, CBRW03674, CBRY02609, CBRX02759, CBRY00715, CBRV00164, CBRV00599, CBRV02217, WBRZ02681, CBRV01580, CBRU02191, CBRU02193, CBRU02190, CBRU02229, CBRU02232, CBRU02233, CBRU02216, CBRU02217, CBRU02224, CBRU02187, CBRU02188, CBRU02189, CBRU02183, CBRU02151, CBRU02150, CBRU02149, CBRU02227, CBRU02228, CBRU02241, CBRU02204, CBRU02548, CBRV00289, CBRW02593, CBRY00771, CBRW02592, CBRW02594, CBRX04572, CBRY00768, CBRU00479, CBRV00584, CBRV00790, CBRV00812, CBRV00810, CBRV00811, CBRV00815, CBRV00807, CBRV00806, CBRV00659, CBRV00791, CBRV00789, CBRV00813, CBRV00805, CBRZ00570, CBRV00558, CBRV00699, CBRV02520, CBRV02509, CBRV02508, CBRV02511, CBRV02521, CBRV02523, CBRV02414, CBRV00827, CBRV00697, CBRW01601, CBRW01566, CBRW01567, CBRW01551, CBRW01564, CBRW01565, CBRW01958, CBRW01956, CBRW01957, CBRW01945, CBRW01941, CBRW01944, CBRW01943, CBRW01942, CBRW01949, CBRW01938, CBRU00119, CBRU00118, CBRV00591, CBRV00581, CBRV00578, CBRV00600, CBRV00594, CBRV00577, CBRV00624, CBRV00604, CBRV00623, CBRV00814, CBRV00828, CBRV02100, CBRV02128, CBRV02124, CBRV02127, CBRV02122, CBRV02120, CBRV02121, CBRV02141, CBRV02140, CBRV02142, CBRV02106, CBRV02110, CBRV02130, CBRV02129, CBRV02103, CBRV02162, CBRV02543, CBRV02522, CBRY00760, CBRY00762, CBRY02164, CBRV00729, CBRV00701, CBRV00379, CBRV00380, CBRV02104, CBRV00783, CBRV00781, CBRV00757, CBRV00817, CBRV00595, CBRV02519, CBRV02564, CBRV00290, CBRX02052, CBRV00552, CBRV00564, CBRV00696, CBRV00658, CBRV00576, CBRV00565, CBRV00553, CBRX02051, CBRX02097, CBRV01790, CBRV01784, CBRV01789, CBRV01787, CBRV01797, CBRV01795, CBRV01792, CBRV01798, CBRV01794, CBRV01764, CBRV01791, CBRV01781, CBRV01779, CBRV01804, CBRV01825, CBRV01808, CBRV01814, CBRV01805, CBRV01810, CBRV01799, CBRV01783, CBRV01796, CBRV01800, CBRV01782, CBRV01766, CBRV01842, CBRV01780, CBRV01768, CBRV01763, CBRV01761, CBRV01771, CBRW01961, CBRW01959, CBRW02474, CBRW02473, CBRW02475, CBRW02491, CBRW02492, CBRW02489, CBRW02510, CBRW02508, CBRW02515, CBRW02538, CBRW02542, CBRW02516, CBRX02936, CBRX03274, CBRX03273, CBRX03576, CBRX04330, CBRX04328, CBRX04329, CBRV02175, CBRV01531, CBRX02479, CBRY00208, CBRU02813, CBRU03489, CBRV00673, CBRV00674, CBRV00677, CBRV00672, CBRV00692, CBRV00682, CBRV00690, CBRV00670, CBRV00669, CBRV00695, CBRX02985, CBRX03020, CBRX03021, CBRX03023, CBRX03025, CBRX03022, CBRX03030, CBRX03056, CBRX03057, CBRX03041, CBRX03026, CBRX03048, WBRB00767, WBRB00768, WBRB00770, WBRB00769, WBRB00749, WBRB00764, WBRB00762, WBRB00761, WBRB00759, WBRB00760, WBRC00553, WBRC00555, WBRC00573, WBRC00572, WBRC00574, WBRC00552, WBRC00554, WBRC00569, WBRC00567, WBRC00563, WBRC00568, WBRC00566, WBRC00564, WBRC00570, WBRC00571, WBRC40012, WBRC40011, WBRC40024, WBRC40023, WBRC40021, WBRC40022, WBRC40020, WBRC00551, WBRC00479, WBRC00478, WBRC00548, WBRC00549, WBRC00550, WBRC00476, WBRC00477, WBRC40019, WBRC40018, WBRC00565, WBRC00561, WBRC40016, WBRC40017, WBRC40015, WBRC00560, WBRC00562, WBRC00559, WBRC40028, WBRC40014, WBRC40013, WBRC40027, WBRC40025, WBRC40026, WBRZ01973, WBRZ01970, WBRZ01975, WBRZ01972, WBRZ01974, WBRZ01968, WBRZ01971, WBRZ01969, WBRZ02125, WBRZ02124, CBRW01216, CBRW01224, CBRX02095, CBRX03253, CBRX03384, CBRX03390, CBRX03394, CBRX03385, CBRX02952, CBRX03457, CBRX03359, CBRX03397, CBRX02713, CBRX03323, CBRX03497, CBRX03311, CBRX03481, CBRX03417, WBRB01293, WBRB01292, WBRB01294, WBRB01041, WBRC00556, WBRC00722, WBRC00651, WBRC00652, WBRC00721, WBRC00720, WBRB01189, WBRC00650, WBRC00732, WBRC00731, WBRC00718, WBRC00719, WBRC00717, WBRC00730, WBRC00714, WBRC00658, WBRC00726, WBRC00727, WBRC00728, WBRC00637, WBRC00724, WBRC00723, WBRC00725, CBRX02050, CBRV00589, CBRV00707, CBRV00713, CBRV00715, CBRV00716, CBRV00714, CBRV00709, CBRV00711, CBRV00710, CBRV00675, CBRV00679, CBRV00712, CBRV00680, CBRV00683, CBRV00686, CBRV00688, CBRV00728, CBRV00720, CBRV00719, CBRV00718, CBRV00727, CBRV00722, CBRV00743, CBRV00668, CBRV00733, CBRV00661, CBRV00738, CBRV00684, CBRW01837, CBRY00839, CBRY00837, CBRY00297, CBRY00207, WBRC00309, WBRC00307, WBRC00308, WBRC00295, WBRC00304, WBRC00305, WBRC00306, WBRC00303, WBRC00300, WBRC00302, WBRC00301, WBRC00293, WBRC00294, WBRC00297, WBRC00299, WBRC00298, WBRC00296, WBRC00292, WBRC00260, WBRC00254, WBRC00257, WBRC00258, WBRC00259, WBRC00290, WBRC00291, WBRC00289, WBRC00287, WBRC00288, WBRC00285, WBRC00286, WBRC00256, WBRC00253, WBRC00255, WBRC00284, WBRC00281, WBRC00280, WBRC00283, WBRC00282, WBRC00252, WBRC00251, WBRC00247, WBRC00246, WBRC00250, WBRC00248, WBRC00249, WBRA01431, WBRA01428, WBRA01429, WBRA01430, WBRC00276, WBRC00277, WBRC00278, WBRC00275, WBRC00274, WBRC00244, WBRC00243, WBRC00245, WBRC00241, WBRC00242, WBRC00279, WBRC00273, WBRC00240, WBRC00375, WBRC00373, WBRC00374, WBRC00378, WBRC00372, WBRC00371, WBRC00237, WBRC00236, WBRC00235, WBRC00239, WBRC00238, WBRC00234, WBRC00368, WBRC00369, WBRC00370, WBRC00366, WBRC00367, WBRC00233, WBRC00272, WBRC00270, WBRC00271, WBRC00269, WBRC00266, WBRC00346, WBRC00343, WBRC00347, WBRC00365, WBRC00362, WBRC00364, WBRC00363, WBRC40044, WBRC00342, WBRC00344, WBRC00341, WBRC00340, WBRC00360, WBRC00361, WBRC00358, WBRC00359, WBRC00407, WBRC00406, WBRC00405, WBRC00403, WBRC00404, WBRC00402, WBRC00353, WBRC00357, WBRC00355, WBRC00354, WBRC00356, WBRC00232, WBRC00330, WBRC00331, WBRC00337, WBRC00339, WBRC00338, WBRC00335, WBRC00336, WBRC00333, WBRC00332, WBRC00334, WBRC00328, WBRC00325, WBRC00351, WBRC00349, WBRC00352, WBRC00348, WBRC00350, WBRC00268, WBRC00265, WBRC00329, WBRC00327, WBRC00326, WBRC00324, WBRC00323, WBRC00322, WBRC00321, WBRC00310, WBRC00320, WBRC00315, WBRC00319, WBRC00345, WBRC00399, WBRC00398, WBRC00393, WBRC00401, WBRC00400, WBRC00397, WBRC00396, WBRC00261, WBRC00263, WBRC00267, WBRC00262, WBRC00264, WBRC00318, WBRC00317, WBRC00316, WBRC00314, WBRC00313, WBRC00312, WBRC00311, WBRC00395, WBRC00394, WBRC00389, WBRC00392, WBRC00391, WBRC00390, WBRC00386, WBRC00388, WBRC00387, WBRC00384, WBRC00385, WBRC00381, WBRC00383, WBRC00380, WBRC00376, WBRC00377, WBRC00382, WBRC00379, WBRC40032, CBRW03543, CBRW03539, CBRW03540, CBRW03542, CBRW03538, CBRW03580, CBRW03576, CBRW03583, CBRW03592, CBRW03577, CBRW03541, CBRW03535, CBRW03590, CBRW03534, CBRW03582, CBRW03581, CBRW03587, CBRW03585, CBRW03591, CBRW03586, CBRW03584, CBRW03563, CBRX04025, CBRX00396, CBRX00467, CBRU00698, CBRY02114, CBRT00247, CBRT00246, CBRU03273, CBRU03274, CBRU03310, CBRU03303, CBRU03306, CBRX03286, CBRX03347, CBRV00708, CBRU02968, CBRY00841, CBRX00666, CBRX00971, CBRV01788, CBRV01821, CBRU00690, CBRU00693, CBRU00744, CBRU00743, CBRU00749, CBRU00748, CBRU00688, CBRU00682, CBRU00685, CBRU00747, CBRT00574, CBRV00689, CBRV00717, CBRV00706, CBRX00399, CBRX02502, CBRX02603, CBRX02576, CBRX02602, CBRX02596, CBRX02607, CBRX02612, CBRX02621, CBRX02608, CBRX02486, CBRX02620, CBRX02429, CBRX02611, CBRX02540, CBRX02614, CBRX02601, CBRX02533, CBRX02622, CBRX02554, CBRX02628, CBRX02586, CBRX02595, CBRX02625, CBRX02627, CBRX02623, CBRX02604, CBRX02610, CBRX02444, CBRX02617, CBRX02605, CBRX02606, CBRX02619, CBRX02600, CBRX02616, CBRX02618, CBRX02609, CBRX02624, CBRX02613, CBRX02626, CBRT00111, CBRT00151, CBRU00125, CBRX01978, CBRX01975, CBRT00110, CBRT00156, CBRT00149, CBRT00153, CBRT00147, CBRU00254, CBRU03171, CBRV00694, CBRV00721, WBRC00605, WBRC00604, CBRV00691, CBRU00817, CBRU00820, CBRU00822, CBRU00816, CBRU00819, CBRW01001, CBRW01004, CBRW01003, CBRW01002, CBRW01006, CBRW01007, CBRX01063, CBRX01064, CBRX00667, CBRX00969, WBRC00729, CBRV00702, CBRY00834, CBRY00835, CBRU03281, CBRV00693, CBRX00422, CBRY00838, WBRA00546, WBRA00545, CBRW01118, CBRW01117, CBRV02914, CBRX01974, CBRT00113, CBRT00148, CBRV00700, CBRX00671, CBRX03955, CBRX03956, CBRX03954, CBRX03940, CBRX03946, CBRX03953, CBRX03952, CBRX03950, CBRX03942, CBRX03939, CBRX03943, CBRX03941, CBRX03945, CBRX03957, CBRX03944, CBRX03951, CBRW02163, CBRU00253, CBRU03299, CBRX00397, CBRX00286, CBRX00970, CBRW03192, CBRW03266, CBRW03269, CBRW01847, CBRW01969, CBRW02015, CBRW01219, CBRW01209, CBRW01214, CBRW01239, CBRY00908, CBRY02322, CBRW02009, CBRW00528, CBRW00549, CBRW00562, CBRW00404, CBRW03600, CBRX00651, CBRW00534, CBRW01196, CBRW03635, CBRW02006, CBRX00673, CBRX00626, CBRV01943, CBRV01594, CBRY00619, CBRY00620, CBRY00634, CBRX01409, CBRX01410, CBRX01866, CBRX01889, CBRX01882, CBRU00401, CBRU00400, CBRU00413, CBRV01596, CBRX00670, CBRX00662, CBRX01411, CBRY01523, CBRY01524, CBRY01666, CBRY01665, CBRY02994, CBRY03015, CBRX00663, CBRW01197, CBRW02012, CBRW02027, CBRW02113, CBRU00799, CBRW02031, CBRW02111, CBRW02118, CBRW03630, CBRX00668, CBRX00623, CBRW01195, CBRW01229, CBRW01225, CBRW01208, CBRX00669, CBRX00652, CBRX00650, CBRU02185, CBRU02245, CBRU02618, CBRU02615, CBRV01915, CBRV01916, CBRW00402, CBRV01919, CBRV01944, CBRV01940, CBRV01927, CBRV01936, CBRV01905, CBRU00409, CBRU00411, CBRV01538, CBRV01592, CBRV01541, CBRV01539, CBRV01591, CBRV01913, CBRV01912, CBRV01937, CBRW03593, CBRW03639, CBRW03636, CBRW01233, CBRW01240, CBRW01227, CBRW02004, CBRW02057, CBRW03628, CBRW03627, CBRW01213, CBRW02003, CBRW02022, CBRW02030, CBRW03626, CBRW03638, CBRW00420, CBRW00421, CBRX00649, CBRY01133, CBRY02538, CBRV02678, CBRV02677, CBRW02054, CBRY02993, CBRY03016, CBRU00808, CBRV02517, CBRV02515, CBRV02513, CBRV02512, CBRV02505, CBRV02743, CBRV02742, CBRV02768, CBRV02680, CBRV02681, CBRY03322, CBRY01538, CBRV01537, CBRW02016, CBRW02059, CBRW02062, CBRW03622, CBRW03623, CBRW03629, CBRW02058, CBRW01220, CBRX01406, CBRW00526, CBRY00922, CBRW02479, CBRW02476, CBRW02477, CBRW02478, CBRW02488, CBRW02469, CBRW02470, CBRW02505, CBRW02495, CBRW02509, CBRW02517, CBRW02519, CBRW02523, CBRW02624, CBRW02645, CBRW02651, CBRW02649, CBRW02643, CBRW02650, CBRW02630, CBRY00587, CBRY00501, CBRY01322, CBRY01385, CBRY01334, CBRY01471, CBRY02021, CBRY02148, CBRY02153, CBRY02150, CBRY02149, CBRY02152, CBRY02200, CBRY02151, CBRY02176, CBRY02177, CBRY02269, CBRY02267, CBRY02268, CBRY02253, CBRY02251, CBRY02252, CBRY02307, CBRY02254, CBRY02265, CBRY02266, CBRY02256, CBRY02154, CBRY02320, CBRY02330, CBRY02653, CBRT00599, CBRT00597, CBRU00807, 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CBRW01262, CBRW00503, CBRW00406, CBRW00415, CBRW00428, CBRW00490, CBRW00407, CBRW00413, CBRW01264, CBRW01260, CBRW01250, CBRW01261, CBRW02005, CBRW02019, CBRW01987, CBRW01988, CBRW02302, CBRW03181, CBRX01267, CBRX02943, CBRX02949, CBRX02942, CBRX03331, CBRW00403, CBRW00508, CBRW00455, CBRW00438, CBRX01431, CBRX01445, CBRX01444, CBRX01447, CBRY03166, CBRY01880, CBRX02954, CBRX02953, CBRY03279, CBRY03280, CBRY03274, CBRY03275, CBRY03272, CBRY03284, CBRY00775, CBRY00890, CBRY03142, CBRY03278, CBRY03283, CBRY03273, CBRY03277, CBRY03271, CBRY03165, CBRW03287, CBRW03267, CBRW03268, CBRW03284, CBRW02762, CBRW03286, CBRW01258, CBRW01259, CBRW01245, CBRW01243, CBRW01248, CBRW02672, CBRW03254, CBRW03255, CBRW03274, CBRW03288, CBRW03283, CBRW03285, CBRW03291, CBRW03210, CBRW02596, CBRW02595, CBRY03168, CBRW01252, CBRW01255, WBRC40033, CBRU02478, CBRU02479, CBRV00586, CBRV01233, CBRW00795, CBRW01150, CBRW01148, CBRX01104, CBRU02468, CBRU02476, CBRU02472, CBRU02470, CBRU02471, CBRU02474, CBRU02481, CBRU02469, CBRU02466, CBRU02463, CBRY03192, CBRY03202, CBRY03211, CBRY03217, CBRY03213, CBRY03216, CBRY03208, CBRY03214, CBRY03209, CBRT00365, CBRT00369, CBRT00368, CBRT00367, CBRT00366, CBRT00364, CBRU00196, CBRU00364, CBRU02312, CBRU02309, CBRU02315, CBRU02310, CBRU02316, CBRU02314, CBRU02313, CBRU02317, CBRU02318, CBRU02308, CBRU02307, CBRU02322, CBRU02319, CBRY00438, CBRY03153, CBRY03154, CBRY03151, CBRX03638, CBRX03617, CBRX03611, CBRX03616, CBRX03620, CBRX03605, CBRX03603, CBRX03604, CBRX03634, CBRX03635, CBRX03628, CBRX03625, CBRX03626, CBRX03580, CBRX03582, CBRX03615, CBRX03612, CBRX03629, CBRX03583, CBRX03584, CBRX03592, CBRX03601, CBRX03594, CBRX03593, CBRX03595, CBRX03600, CBRX03602, CBRX03590, CBRX03557, CBRY00475, CBRY00472, CBRY00469, CBRY03089, CBRY03081, CBRY03085, CBRY03072, CBRY03080, CBRY03082, CBRY03076, CBRY03066, CBRY03070, CBRY03083, CBRY03152, WBRA00035, WBRZ01823, WBRZ01860, WBRZ01858, WBRZ01830, WBRZ01827, WBRZ01824, WBRZ01825, WBRZ01829, WBRZ01863, WBRZ01857, WBRZ01861, WBRZ01862, WBRZ01859, WBRZ01855, WBRZ01856, WBRZ01853, WBRZ01854, WBRZ03083, WBRZ03080, WBRZ03082, WBRZ03081, WBRZ01831, WBRZ01828, WBRZ01826, WBRZ03085, WBRZ03084, WBRZ03087, WBRA00034, WBRZ03086, WBRZ03088, WBRZ03089, WBRA00045, WBRA00040, WBRA00043, WBRA00042, WBRA00041, WBRA00039, WBRA00044, WBRA00038, WBRA00036, WBRA00037, WBRA00033, WBRA00032, WBRA00031, WBRA00046, CBRY02942, CBRY02941, CBRY02946, CBRY02947, CBRY02948, CBRW02741, CBRW02742, CBRW02751, CBRW02756, CBRX00737, CBRX00760, CBRX00767, CBRY02933, CBRY02931, CBRY02938, CBRY02940, CBRY02939, CBRX02947, CBRW01368, CBRY02759, CBRY02882, CBRY01865, CBRX04580, CBRY02935, CBRY02934, CBRY02936, CBRY02937, CBRY02944, CBRY02945, CBRY02943, WBRZ02534, WBRZ02533, WBRZ02531, WBRZ02532, WBRZ02865, WBRZ02867, WBRZ02864, WBRZ02855, WBRZ02868, WBRZ02866, WBRZ02942, WBRZ02945, WBRZ02946, WBRZ02947, WBRZ02944, WBRZ02948, WBRZ02949, WBRZ02950, WBRZ02951, WBRZ02953, WBRZ02952, WBRZ02954, WBRZ02857, WBRZ02854, WBRZ02859, WBRZ02856, WBRZ02858, WBRZ02860, WBRZ02861, WBRZ02863, WBRZ02862, WBRZ02939, WBRZ02940, WBRZ02941, WBRZ02943, WBRZ02683, WBRZ02682, WBRZ02902, WBRZ02903, WBRZ02899, WBRZ02537, WBRZ02535, WBRZ02536, WBRZ02539, WBRZ02540, WBRZ02538, WBRZ02898, WBRZ02900, WBRZ02897, WBRZ02901, CBRV02748, CBRV02717, CBRV02747, CBRV02896, CBRV02897, CBRV02884, CBRV02806, CBRV02851, CBRV02659, CBRV02658, CBRV02657, CBRV02656, CBRV02852, CBRV02847, CBRV02725, CBRU03485, CBRU03484, CBRX00785, CBRX00786, CBRX00797, CBRX03015, CBRY00990, CBRY00988, CBRU00198, WBRB00414, WBRZ01942, WBRZ01945, WBRZ02144, WBRZ02226, WBRZ02275, WBRZ02524, WBRZ02289, WBRZ01944, WBRZ01943, WBRZ02133, WBRB00247, WBRB00272, WBRZ02282, WBRZ02530, WBRZ02514, WBRB00288, WBRB00249, WBRB00465, WBRB00259, WBRZ02274, WBRZ02290, WBRZ02383, WBRZ02382, WBRZ02516, WBRB00262, WBRZ02147, WBRZ02146, WBRZ02285, WBRZ02280, WBRZ02279, WBRZ02283, WBRZ02143, WBRZ02224, WBRZ02227, WBRZ02228, WBRZ02273, WBRZ02278, WBRZ02277, WBRZ02276, WBRZ02528, WBRZ02529, WBRZ02272, WBRZ02291, WBRZ01967, WBRZ01966, WBRZ02287, WBRZ02288, WBRZ02389, WBRZ02387, WBRZ02522, WBRZ02520, WBRZ02519, WBRZ02518, WBRZ02521, WBRZ02130, WBRZ02131, WBRZ02132, WBRZ02128, WBRZ02127, WBRZ02380, WBRZ02384, WBRZ02511, WBRZ02509, WBRZ02515, WBRZ02510, WBRB00255, WBRB00253, WBRB00290, WBRB00289, WBRB00252, WBRB00251, WBRB00248, WBRB00287, WBRB00286, WBRB00284, WBRB00283, WBRB00280, WBRB00279, WBRB00278, WBRB00463, WBRB00240, WBRB00241, WBRB00246, WBRB00244, WBRB00243, WBRB00242, WBRB00239, WBRB00238, WBRB00275, WBRB00277, WBRB00233, WBRB00235, WBRB00236, WBRB00237, WBRB00234, WBRB00274, WBRB00269, WBRB00273, WBRB00270, WBRB00271, WBRB00268, WBRB00264, WBRB00266, WBRB00267, WBRB00263, WBRB00232, WBRB00438, WBRB00439, WBRB00437, WBRB00435, WBRB00433, WBRB00434, WBRB00440, WBRB00260, WBRB00258, WBRB00261, WBRZ02145, WBRZ02527, WBRB00257, WBRB00250, WBRB00282, WBRB00285, WBRB00276, WBRZ02284, WBRZ02523, WBRZ02517, WBRB00256, WBRZ02129, WBRZ02385, WBRZ02512, WBRB00254, WBRB00281, WBRB00265, 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CBRX01269, CBRX01264, CBRY00437, CBRY00435, CBRY00427, CBRY00421, CBRW02013, CBRX00101, CBRX00335, CBRX00509, CBRX00352, WBRA01401, WBRA00539, WBRA00541, WBRA00540, WBRA00537, CBRV00435, WBRA00538, CBRU02458, CBRW01184, CBRZ00204, WBRB00027, WBRB00026, WBRB00025, WBRB00024, WBRB00028, WBRB00029, WBRB00022, WBRB00023, WBRA01400, WBRC00483, WBRC00484, CBRW03625, CBRW03624, CBRY00439, CBRY00436, CBRY00441, CBRY00442, CBRY00445, CBRY00446, CBRY00447, CBRY00453, CBRY00407, CBRY00451, CBRW02011, CBRY00730, WBRC00459, WBRC00460, WBRC00461, WBRC00458, WBRC00465, WBRC00463, WBRC00462, WBRC00464, WBRC00066, CBRW02472, CBRW02471, CBRW02533, CBRW02525, CBRW02528, WBRA01399, CBRU00470, CBRW02460, CBRW02461, CBRW02453, CBRW02454, CBRW02455, CBRW02457, CBRW02452, CBRW02446, CBRW02451, CBRW02456, CBRX00170, CBRX00173, CBRX00687, CBRX00682, CBRX00688, CBRX00680, CBRX00986, CBRX01018, CBRX01026, CBRX01021, CBRX00982, CBRX00992, CBRX01047, CBRX01037, CBRX01038, CBRX01031, CBRX01028, CBRX01036, CBRX00987, CBRX00991, CBRX01032, CBRX01046, CBRX01027, CBRX01025, CBRX01045, CBRX01019, CBRX01023, CBRX01266, CBRX01282, CBRX01293, CBRX01298, CBRX01278, CBRX01270, CBRX01268, CBRX01290, CBRX01299, CBRX01249, CBRX01284, CBRX01287, CBRX01283, CBRX01251, CBRX01255, CBRX01294, CBRX01277, CBRX01295, CBRY01111, CBRW01553, CBRZ00742, CBRZ00743, CBRV00383, CBRV00382, CBRZ00745, CBRZ00744, CBRZ00741, CBRX03305, CBRZ00508, CBRZ00506, CBRZ00509, CBRZ00512, CBRU02248, CBRU02297, CBRU02545, CBRU02570, CBRU03071, CBRU03074, CBRV00146, CBRV00140, CBRV00148, CBRV00143, CBRV00142, CBRV00144, CBRV00141, CBRV00147, CBRV00145, CBRV00139, CBRV00137, CBRV00138, CBRV00748, CBRV01601, CBRV01734, CBRV01726, CBRV01709, CBRV01692, CBRV01688, CBRV01906, CBRV02260, CBRV02541, CBRV02698, CBRV02567, CBRV02557, CBRV02999, CBRV02996, CBRV02998, CBRW00147, CBRW00181, CBRW00190, CBRW00189, CBRW00182, CBRW00205, CBRW00171, CBRW00170, CBRW00144, CBRW00850, CBRW00838, CBRW00824, CBRW00819, CBRW00822, CBRW00823, CBRW00847, CBRW00837, CBRW00852, CBRW00821, CBRW00858, CBRW00864, CBRW00862, CBRW00857, CBRW00842, CBRW00851, CBRW00856, CBRW00861, CBRW00853, CBRW00855, CBRW00840, CBRW00849, CBRW00846, CBRW00845, CBRW00854, CBRW01975, CBRW01976, CBRW02527, CBRW03419, CBRW03647, CBRX00148, CBRX00138, CBRY00218, CBRY03509, CBRY03508, CBRZ00513, CBRZ00514, CBRZ00549, CBRZ00507, CBRZ00505, CBRW03481, CBRW03650, CBRW03648, CBRX00145, CBRX00150, CBRX00147, CBRX00139, CBRX00149, CBRX01633, CBRX04195, CBRY00223, CBRY00594, CBRU00649, CBRX02745, CBRT00380, CBRW01998, CBRW01985, CBRW01995, CBRW01951, CBRW01997, CBRW01996, CBRW01977, CBRW01978, CBRX02752, CBRW01989, CBRT00381, CBRU03158, CBRY01504, CBRV00930, CBRV00929, CBRV00925, CBRV00923, CBRV00924, CBRV00922, CBRV00579, CBRV00662, CBRX03571, CBRX03570, CBRV00326, WBRC00575, WBRC00583, WBRC00582, CBRU02698, CBRU02699, CBRU00658, CBRV00506, CBRX01225, CBRV00638, CBRU00501, CBRV01579, CBRV01578, CBRY03513, CBRY03374, CBRY03372, CBRY03376, CBRW03259, CBRW03271, CBRW03258, CBRW03202, CBRW03220, CBRU02414, CBRU02412, CBRU02413, CBRX04188, WBRC00716, WBRC00715, CBRW03180, CBRV02868, CBRV02862, CBRV02953, CBRV02869, CBRV02947, CBRV02863, CBRV03087, CBRV03084, CBRV03083, CBRV03091, CBRV03090, CBRW00879, CBRX02364, CBRX02366, CBRX02378, CBRX02382, CBRX02481, CBRX02527, CBRY01512, CBRY01513, CBRY01519, CBRY01518, CBRY01554, CBRY01558, CBRY01550, CBRY01511, CBRY01510, CBRY01551, CBRY01553, CBRY01552, CBRW00304, CBRW00302, CBRW00303, CBRW00301, CBRW00285, CBRW00284, CBRW00316, CBRX00939, CBRX00931, CBRX00937, CBRX00945, CBRX00943, CBRX00944, CBRX00954, CBRX00951, CBRX00940, CBRX00946, CBRX00941, CBRX00955, CBRX00953, CBRX00952, CBRX00956, CBRX01628, CBRX01634, CBRX01635, CBRY01163, CBRY01166, CBRY01167, CBRY00916, CBRY01169, CBRY01140, CBRY02097, CBRY02219, CBRY02202, CBRY02289, CBRY02288, CBRY02290, CBRY02099, CBRY02104, CBRY02096, CBRY02112, CBRY02159, CBRY02235, CBRY02234, CBRY03026, CBRW03182, CBRW03186, CBRW03185, CBRY01981, CBRY00898, CBRY01155, CBRY00947, CBRY01138, CBRY01154, CBRY00945, CBRY03319, CBRY03315, CBRY03313, CBRY03314, CBRY03327, CBRY00961, CBRX02373, CBRX02503, CBRX02471, CBRX02476, CBRX02472, CBRX02478, CBRX02447, CBRX02445, CBRY02340, CBRX02484, CBRX02482, CBRX02485, CBRY02119, CBRY03004, CBRY03001, CBRY03003, CBRX03357, CBRX03545, CBRY02368, CBRY01980, CBRY02270, CBRY02113, CBRY02108, CBRW01973, CBRX02118, CBRX02104, CBRX02112, CBRX02115, CBRX02113, CBRX02111, CBRX02110, CBRX02114, CBRX02106, CBRX02120, CBRY00845, CBRY00843, CBRY00846, CBRY00847, CBRW01242, CBRX04087, CBRX04085, CBRW03694, CBRX01623, CBRX01631, CBRX01622, CBRX01629, CBRX01630, CBRV02477, CBRV02792, CBRV02550, CBRV02549, CBRV02946, CBRV02944, CBRV02942, CBRV02945, CBRV02951, CBRV02952, CBRV02927, CBRV02926, CBRV02930, CBRV02547, CBRY02490, CBRY02560, CBRY02545, CBRY02541, CBRY02540, CBRY03321, CBRY03320, CBRY03251, CBRY03257, CBRY03250, CBRY03261, CBRY03259, CBRY03262, CBRW02008, CBRW02007, CBRW03165, CBRW03167, CBRX02548, CBRX02551, CBRX02545, CBRX02544, CBRX02530, CBRX02918, CBRW01454, CBRW01470, CBRW01449, CBRW01456, CBRW01450, CBRW01469, CBRW01475, CBRW01471, CBRW01472, CBRW01446, CBRW01692, CBRY01780, CBRY01783, CBRX03306, CBRX03494, CBRY02040, CBRY01910, CBRY02026, CBRW01665, CBRW01664, CBRX00420, CBRX00424, CBRX00403, CBRX00506, CBRY02303, CBRX02501, CBRX03540, CBRX03562, CBRX02363, CBRX02379, CBRX02362, CBRX02380, CBRX02526, CBRX02564, CBRX02552, CBRX02525, CBRX02570, CBRX02565, CBRX02880, CBRY01782, CBRY01785, CBRX02491, CBRX02940, CBRX03341, CBRX03308, CBRV02719, CBRV02545, CBRV03036, CBRW00131, CBRW00817, CBRW00818, CBRW02589, CBRW02622, CBRW02618, CBRW02619, CBRW02623, CBRW02626, CBRW02646, CBRW02647, CBRW02668, CBRW02625, CBRW03683, CBRW03474, CBRX00653, CBRX00686, CBRX00685, CBRX00678, CBRX00684, CBRX00681, CBRX00645, CBRX00665, CBRX00691, CBRX00679, CBRX00694, CBRX00730, CBRX00718, CBRX00716, CBRX00719, CBRX00704, CBRX00702, CBRX00654, CBRX00659, CBRX00660, CBRX00696, CBRX00693, CBRX00636, CBRX00646, CBRX00637, CBRX00717, CBRX00683, CBRX00647, CBRX00695, CBRX00644, CBRX00692, CBRX00640, CBRX00641, CBRX00648, CBRX00742, CBRX01067, CBRX02393, CBRX02394, CBRX02397, CBRX02383, CBRX02550, CBRX02532, CBRX02398, CBRX02477, CBRX02549, CBRX02541, CBRX02535, CBRX02543, CBRX02395, CBRX02538, CBRX02384, CBRX02531, CBRX03342, CBRX03383, CBRX03396, CBRX03360, CBRX03395, CBRX03532, CBRX03533, CBRX03404, CBRX03391, CBRX03453, CBRX03398, CBRX03507, CBRX03525, CBRX03528, CBRX03524, CBRY00616, CBRY00868, CBRY00862, CBRY00853, CBRY00872, CBRY00879, CBRY00871, CBRY00854, CBRY00214, CBRY00884, CBRY00886, CBRY00885, CBRY00881, CBRY00888, CBRY00869, CBRY00857, CBRY00910, CBRY00905, CBRY00912, CBRY00911, CBRY00895, CBRY00909, CBRY00900, CBRY00874, CBRY00865, CBRY00889, CBRY00891, CBRY00969, CBRY01020, CBRY01029, CBRY01025, CBRY01011, CBRY00882, CBRY00204, CBRY01017, CBRY01014, CBRY00243, CBRY00222, CBRY00963, CBRY00894, CBRY00860, CBRY00892, CBRY01012, CBRY01016, CBRY01026, CBRY00213, CBRY01033, CBRY01041, CBRY01042, CBRY01047, CBRY01030, CBRY01031, CBRY00918, CBRY01056, CBRY00200, CBRY01088, CBRY01087, CBRY01086, CBRY01089, CBRY01096, CBRY01090, CBRY00875, CBRY01015, CBRY00876, CBRY00915, CBRY01023, CBRY01059, CBRY01076, CBRY01083, CBRY01085, CBRY01007, CBRY01204, CBRY01206, CBRY01205, CBRY01203, CBRY01236, CBRY01237, CBRY01225, CBRY01223, CBRY01228, CBRY01214, CBRY01219, CBRY01216, CBRY01221, CBRY01900, CBRY02549, CBRX03526, CBRX03531, CBRV03000, CBRV03015, CBRV03014, CBRV03018, CBRV03016, CBRV03047, CBRX02371, CBRX02427, CBRX02536, CBRX02537, CBRX02542, CBRX02431, CBRX02480, CBRX02539, CBRX03330, CBRX02037, CBRY02047, CBRY02046, CBRY02038, CBRY02048, CBRX03307, CBRX03322, CBRY02493, CBRX02396, CBRW01535, CBRW01533, CBRW01531, CBRW01536, CBRW01532, CBRW01534, CBRY01789, CBRW02402, CBRW02408, CBRW02396, CBRW02389, CBRW02397, CBRW02400, CBRW02401, CBRW02399, CBRW02409, CBRW03664, CBRW03684, CBRW03662, CBRW03663, CBRW01459, CBRW01457, CBRW01455, CBRW01180, CBRW01452, CBRW01462, CBRW01466, CBRW01461, CBRY02566, CBRY03179, CBRY03285, CBRY03276, CBRX01191, CBRX02555, CBRX02529, CBRY01786, CBRX02370, CBRX02369, CBRX02368, CBRX02367, CBRX02430, CBRX02453, CBRY02498, CBRW03696, CBRW03693, CBRV03067, CBRV03068, CBRV03066, CBRV03069, CBRV03070, CBRV03074, CBRX02377, CBRX02556, CBRX02475, CBRX02557, CBRX02469, CBRX02495, CBRX03329, CBRY02373, CBRX02483, CBRX03358, CBRX03295, CBRW01657, CBRW01654, CBRW01666, CBRY01417, CBRY01416, CBRX00401, CBRX00434, CBRW01653, CBRW01656, CBRW01640, CBRY01414, CBRY01412, CBRY01413, CBRY01415, CBRY01408, CBRY02979, CBRX02435, CBRX02433, CBRX02437, CBRX024

Distribution pattern

Worldwide

device · product 2 of 3

EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

Z-0775-2024

Recall number: Z-0775-2024
Initiated: December 29, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Datex-Ohmeda, Inc.
Quantity: 12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

UDI/DI ********, Serial Numbers: CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, CBCU00559

Distribution pattern

Worldwide

device · product 3 of 3

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;

Z-0776-2024

Recall number: Z-0776-2024
Initiated: December 29, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Datex-Ohmeda, Inc.
Quantity: 1294 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

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

Distribution pattern

Worldwide