Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019 — FDA record Z-1285-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Reason
Backup batteries can fail earlier than their estimated life.
Classification
Class II
Recalling firm
GE Healthcare, LLC
Quantity
6,612 devices
Agency-reported status
Ongoing
Source record identifier
Z-1285-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityModel Number: 1009-9050-000; UDI/DI: 00840682102322; Serial Numbers: APKB00323, APKB00324, APKB00325, APKB00326, APKB00327, APKB00328, APKZ01002, APKB00236, APKB00237, APKB00238, APKB00239, APKB00240, APKA00595, APKA00596, APKA01159, APKB00159, APKB00241, APKB00242, APKB00243, APKB00244, APKB00245, APKB00246, APKB00247, APKB00248, APKB00249, APKB00250, APKB00308, APKB00309, APKY01153, APKY01219, APKY02040, APKY02041, APKY02401, APKY02402, APKY02403, APKY02404, APKY02405, APKY02406, APKY02407, APKY02408, APKY02409, APKY02410, APKY02411, APKY02412, APKY02413, APKY02414, APKY02415, APKY02416, APKY02417, APKY02418, APKY02419, APKY02420, APKY02421, APKY02422, APKY02423, APKY02424, APKY02425, APKY02426, APKY02427, APKY02428, APKY02429, APKY02430, APKY02431, APKY02432, APKY02433, APKY02434, APKY02435, APKY02436, APKY02437, APKY02438, APKY02439, APKY02440, APKY02441, APKY02442, APKY02443, APKY02444, APKY02445, APKY02446, APKY02447, APKY02448, APKY02449, APKY02450, APKY02451, APKY02452, APKY02453, APKY02454, APKY02455, APKY02456, APKY02457, APKY02458, APKY02459, APKY02460, APKY02461, APKZ00107, APKZ00108, APKZ00109, APKZ00110, APKZ00111, APKZ00112, APKZ00113, APKZ00516, APKZ00517, APKZ01733, APKZ01734, APKZ01735, APKZ01736, APKZ01437, APKZ00843, APKZ00844, APKZ00845, APKZ00846, APKZ00847, APKZ00848, APKZ00889, APKZ00890, APKZ00891, APKZ00892, APKZ00893, APKZ00894, APKA00876, APKA01882, APKA01883, APKA01884, APKY00920, APKB00257, APKB00258, APKB00259, APKB00260, APKB00261, APKB00262, APKB00263, APKB00264, APKB00265, APKA00316, APKY02395, APKY02396, APKA00404, APKA01969, APKB00330, APKB00331, APKB00332, APKB00333, APKB00334, APKB00335, APKB00336, APKB00337, APKY02107, APKY02509, APKY02510, APKY02511, APKY02512, APKY02513, APKY02514, APKY02573, APKY02574, APKZ00398, APKZ01001, APKZ01844, APKY01718, APKY01719, APKY01720, APKZ00637, APKZ01007, APKZ01153, APKA00188, APKA00189, APKZ01703, APKZ01703, APKZ01704, APKZ01704, APKZ01705, APKZ01705, APKZ01706, APKZ01706, APKZ01707, APKZ01707, APKZ01708, APKZ01708, APKZ01709, APKZ01709, APKZ01710, APKZ01710, APKZ01960, APKA01148, APKA01149, APKA00283, APKA00284, APKA00503, APKA01086, APKA01087, APKA01088, APKA01089, APKA01090, APKZ00175, APKZ01614, APKZ02013, APKZ02014, APKZ02015, APKA00285, APKB00130, APKB00131, APKB00132, APKB00133, APKB00134, APKB00135, APKB00136, APKB00137, APKB00445, APKZ02336, APKZ02337, APKY02545, APKY01540, APKY01541, APKY01542, APKA01073, APKA01074, APKA01075, APKA01076, APKA01077, APKA01078, APKZ02320, APKZ01994, APKZ01995, APKY00913, APKY00914, APKY00915, APKY01006, APKY01007, APKZ01665, APKZ01761, APKZ01820, APKA00427, APKB00164, APKB00165, APKB00166, APKB00167, APKB00168, APKB00169, APKB00404, APKB00300, APKB00301, APKB00251, APKB00253, APKB00254, APKB00255, APKB00256, APKB00288, APKB00289, APKB00310, APKY02640, APKY01224, APKY01225, APKY01226, APKY01227, APKY01228, APKY02663, APKY02664, APKY02665, APKY02666, APKY02667, APKY02668, APKY02669, APKY02670, APKY02671, APKY02672, APKY02673, APKA00807, APKA00808, APKA00809, APKA00810, APKA00811, APKA00812, APKA00813, APKA00814, APKB00369, APKB00402, APKB00403, APKB00405, APKB00406, APKB00407, APKZ00696, APKZ00943, APKZ00944, APKY01623, APKZ02151, APKZ02152, APKZ02409, APKZ02410, APKZ02411, APKZ00146, APKZ00147, APKB00252, APKB00287, APKB00290, APKB00291, APKB00292, APKB00293, APKZ02333, APKZ02482, APKZ02483, APKZ02484, APKZ02485, APKZ02486, APKZ02487, APKZ02488, APKZ01800, APKZ01801, APKZ01802, APKZ01803, APKZ01804, APKZ01758, APKZ01759, APKB00297, APKB00298, APKY01252, APKY01253, APKY01254, APKY01255, APKY01256, APKY01624, APKY01625, APKY01834, APKY01883, APKY01884, APKY01887, APKY01888, APKY01835, APKY01928, APKY01929, APKY01930, APKY01931, APKA01246, APKZ00441, APKZ00572, APKZ00573, APKZ00574, APKA00322, APKB00172, APKZ00115, APKB00163, APKZ01996, APKA01727, APKA01926, APKA01927, APKY02569, APKY02570, APKY02571, APKY02572, APKA00400, APKA00401, APKA00402, APKA00403, APKA01002, APKA01003, APKA01004, APKA01005, APKA01006, APKA01007, APKZ00606, APKA00313, APKA00314, APKA00327, APKA00328, APKA00329, APKA00330, APKZ00607, APKY00787, APKZ00329, APKZ00256, APKB00113, APKB00114, APKB00115, APKB00116, APKY01387, APKY01388, APKY01512, APKY01513, APKY01514, APKY01515, APKY01516, APKY01517, APKY01518, APKY01519, APKY01520, APKY01521, APKY01522, APKY01755, APKY01756, APKB00311, APKB00312, APKB00313, APKB00314, APKZ02470, APKZ02471, APKY02544, APKY01904, APKY01905, APKZ02499, APKZ02500, APKZ02501, APKZ02502, APKZ02503, APKZ02504, APKA00362, APKA00618, APKA01720, APKB00383, APKY01783, APKY01784, APKZ00192, APKZ00193, APKZ00194, APKZ00195, APKZ00481, APKZ00486, APKZ02455, APKZ02456, APKZ02457, APKZ02458, APKZ02459, APKZ02460, APKZ02461, APKZ02462, APKZ02463, APKZ02464, APKZ02465, APKZ02466, APKZ00706, APKZ00718, APKZ00720, APKZ00721, APKZ00722, APKA01211, APKA01211, APKA01659, APKB00206, APKB00207, APKB00208, APKB00209, APKY01384, APKY02273, APKY02394, APKZ00258, APKZ00259, APKZ00260, APKZ00406, APKZ00408, APKZ00413, APKZ00482, APKZ00483, APKZ00492, APKA01661, APKA01938, APKA01939, APKB00187, APKY00750, APKY00751, APKA00571, APKA00572, APKA00573, APKA00574, APKA00575, APKA00576, APKY01349, APKY01350, APKY01351, APKY01352, APKY01353, APKY01354, APKY01355, APKY01356, APKY01357, APKY01358, APKY01359, APKY01360, APKY01361, APKY01362, APKY01363, APKY01364, APKY01365, APKY01366, APKY01367, APKY01368, APKY01369, APKY01370, APKY02387, APKZ00415, APKA01682, APKA01683, APKA01684, APKA01685, APKA01686, APKA01687, APKA01688, APKA01689, APKA01690, APKA01691, APKB00472, APKY01246, APKY01247, APKY01248, APKY00999, APKY01000, APKA01319, APKY02467, APKY02468, APKY02469, APKY02470, APKY02471, APKY02472, APKY02473, APKA00801, APKA00310, APKA00311, APKA01670, APKA01671, APKA01672, APKA01673, APKA01674, APKA01675, APKA01676, APKA01677, APKA01678, APKA01679, APKA01680, APKA01681, APKY01249, APKY01250, APKY01251, APKZ00679, APKZ00680, APKZ00681, APKZ01435, APKZ01436, APKB00147, APKB00148, APKB00149, APKB00150, APKB00151, APKB00152, APKB00153, APKB00154, APKB00155, APKB00156, APKB00157, APKB00450, APKY01267, APKY00852, APKY00853, APKY00854, APKY00855, APKA01266, APKA01267, APKA01268, APKA01273, APKZ01283, APKZ01431, APKZ02063, APKZ02064, APKA00705, APKY02675, APKY02676, APKY02677, APKY02678, APKZ00409, APKZ00493, APKA00347, APKA00348, APKA00349, APKA00672, APKA00673, APKA00674, APKY01158, APKZ00988, APKZ00989, APKA01316, APKA01317, APKA01395, APKA01396, APKA01397, APKA01398, APKA01399, APKA01400, APKA01376, APKA01377, APKA01378, APKA01379, APKA01380, APKA01381, APKA01382, APKY01159, APKY01923, APKY01924, APKB00126, APKB00127, APKB00128, APKB00174, APKB00175, APKB00176, APKB00338, APKB00339, APKB00340, APKB00341, APKB00342, APKB00343, APKB00344, APKB00345, APKB00346, APKB00347, APKB00348, APKY02039, APKZ00286, APKZ00287, APKZ01129, APKZ01130, APKZ01131, APKZ01132, APKZ01133, APKZ01134, APKZ01135, APKZ02300, APKZ02301, APKZ02302, APKZ02303, APKZ02304, APKZ02305, APKZ02306, APKZ02307, APKZ02308, APKZ02309, APKZ02310, APKZ02311, APKZ02312, APKZ02313, APKZ02314, APKZ02315, APKZ02553, APKZ02554, APKZ02555, APKZ02556, APKZ02557, APKZ02558, APKZ02559, APKZ02560, APKZ02561, APKZ02562, APKZ02563, APKZ02564, APKZ02565, APKZ02566, APKZ02567, APKZ02568, APKZ02569, APKY01101, APKZ00490, APKZ00491, APKY02674, APKZ02338, APKA00545, APKA00546, APKA00547, APKA00619, APKA00620, APKY00951, APKY00952, APKY00953, APKY00954, APKY00955, APKY00956, APKY00957, APKY00958, APKY00959, APKY00960, APKY00961, APKY00962, APKY00963, APKY00964, APKY00965, APKY00966, APKY01636, APKZ00233, APKZ00234, APKZ00235, APKZ00236, APKZ00237, APKZ00238, APKZ00239, APKZ00240, APKZ00241, APKZ00248, APKZ00249, APKZ00250, APKZ00251, APKY01280, APKY01281, APKY01282, APKY01283, APKY01284, APKY01285, APKZ00693, APKY01591, APKY01592, APKA00244, APKA00245, APKA00246, APKY01529, APKY01530, APKY01959, APKY02488, APKZ01003, APKZ01004, APKZ01005, APKZ01006, APKZ01100, APKZ01101, APKZ01102, APKB00272, APKB00273, APKB00274, APKB00275, APKY02504, APKY02505, APKY02506, APKZ01103, APKA01970, APKA01971, APKA01972, APKY02557, APKY02558, APKY02559, APKY02560, APKY02561, APKY02562, APKY02563, APKY02564, APKA01001, APKA01001, APKY01094, APKY02605, APKY02606, APKZ01920, APKA01791, APKA01792, APKA01793, APKA01794, APKZ00536, APKZ00538, APKZ00539, APKZ00549, APKZ00551, APKZ00552, APKY00262, APKZ01915, APKZ02405, APKZ02406, APKA00776, APKA00777, APKA00778, APKA00779, APKA00781, APKA00782, APKA00829, APKY01580, APKA00465, APKA00466, APKA00467, APKA00468, APKB00271, APKZ01267, APKZ01268, APKY00736, APKY00737, APKY01376, APKY01376, APKY01876, APKY01877, APKY01878, APKY01879, APKY01880, APKY01881, APKY01882, APKY02117, APKZ00252, APKZ00253, APKZ00254, APKZ00255, APKA00742, APKA00978, APKA00979, APKA00981, APKA00982, APKA00983, APKA00984, APKA00985, APKA00986, APKA00987, APKA00988, APKA01012, APKA00430, APKZ00433, APKA00741, APKA00980, APKA01008, APKA01009, APKA01010, APKA01011, APKA01013, APKA01014, APKA01015, APKA01016, APKA01017, APKA01018, APKA01019, APKA01020, APKA01021, APKA01022, APKA01023, APKA01024, APKZ00435, APKZ00436, APKA00469, APKA00470, APKA00471, APKA00472, APKA00473, APKA00474, APKY01392, APKY01393, APKA00740, APKA00786, APKA00911, APKA00912, APKA00913, APKA00914, APKA00915, APKA00916, APKA00917, APKA00918, APKA00919, APKA00920, APKA00921, APKA00922, APKA01025, APKA01026, APKA01027, APKA01028, APKA01029, APKA01030, APKA01031, APKA01032, APKA01033, APKA01034, APKA01035, APKA01036, APKA01037, APKA01038, APKA01039, APKA01040, APKA01041, APKA01042, APKA01043, APKA01044, APKA01045, APKA01046, APKA01047, APKA01048, APKA01049, APKA01050, APKA01051, APKA00492, APKA00493, APKA00494, APKA00594, APKZ00330, APKZ00331, APKZ00332, APKZ00333, APKZ00541, APKA00429, APKA00479, APKA01150, APKB00462, APKB00511, APKB00512, APKB00513, APKB00515, APKB00516, APKY01567, APKY01568, APKY01569, APKY01570, APKY01571, APKY01572, APKY01573, APKZ00669, APKZ02105, APKZ02106, APKA00363, APKA00364, APKY02393, APKZ02157, APKZ02158, APKZ02159, APKZ02160, APKZ02161, APKZ02162, APKZ02163, APKZ02164, APKZ02165, APKZ02166, APKZ02167, APKZ02168, APKB00466, APKB00467, APKY01457, APKA01262, APKY02052, APKY02053, APKY02054, APKY02055, APKY00639, APKY00640, APKY00641, APKY00642, APKY00643, APKY00644, APKY00645, APKY00646, APKY00647, APKY00648, APKY00649, APKY00650, APKY00651, APKY00652, APKY00653, APKY00654, APKY00655, APKY00656, APKY00657, APKY00658, APKY00659, APKY00660, APKY00661, APKY00662, APKY00663, APKY00664, APKY00665, APKY00666, APKA01185, APKA01186, APKA01335, APKB00485, APKY02592, APKY02593, APKY02594, APKY02595, APKY02596, APKY02597, APKY02598, APKY02599, APKY02600, APKY02601, APKY02602, APKY02603, APKY02604, APKY02688, APKY02689, APKY02690, APKY02700, APKA01052, APKA01053, APKA01054, APKA01441, APKA01442, APKA01443, APKA01444, APKA01445, APKA01460, APKA01144, APKA01145, APKY01545, APKY01546, APKY01547, APKY01548, APKY01549, APKY01550, APKY01551, APKA01719, APKB00182, APKZ00322, APKZ00323, APKA00343, APKA00344, APKZ01428, APKZ01429, APKA00783, APKA00784, APKB00140, APKB00141, APKB00142, APKB00143, APKA01193, APKA01194, APKA01195, APKA01196, APKA01197, APKA01198, APKA01199, APKA01200, APKA01201, APKA01202, APKB00111, APKB00170, APKB00171, APKB00415, APKZ00601, APKZ00602, APKZ01757, APKY00912, APKZ02282, APKZ02283, APKZ02284, APKZ02285, APKZ02286, APKZ02287, APKZ02288, APKZ01689, APKZ01750, APKZ01751, APKZ01753, APKZ01825, APKY02591, APKA00333, APKA00334, APKA00335, APKA00336, APKA00337, APKA00338, APKA00339, APKA00340, APKA00385, APKA00386, APKA00387, APKA00388, APKA00389, APKA00390, APKA00391, APKA01152, APKZ00149, APKY00686, APKZ00488, APKA00831, APKA00696, APKY01702, APKY02078, APKA00713, APKA00714, APKA00715, APKA00716, APKA00717, APKA00718, APKA00885, APKA01153, APKA01154, APKA01155, APKA01156, APKA01157, APKB00295, APKB00296, APKY01109, APKY01110, APKY01111, APKY01112, APKY02061, APKZ01146, APKZ01147, APKY01966, APKA01171, APKA01172, APKA01173, APKA01174, APKA01175, APKA01176, APKA01177, APKA...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Kenya, Korea, Kuwait, Lao PDR, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Nepal, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jul 6, 2022
Recall initiation date
Apr 25, 2022
Center classification date
Jun 24, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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