Recall archive / FDA device enforcement
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
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model 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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.