FDA · Medical device recall

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices… and 1 more product

July 6, 2022 Class II

Date: July 6, 2022
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: GE Healthcare, LLC
Reason: Backup batteries can fail earlier than their estimated life.
Distribution pattern: 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.

2 products in this recall

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1…

Product: Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Quantity: 6,612 devices
Codes and lots: 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…
Recall started: April 25, 2022
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Under Investigation by firm
What the company told customers: An Urgent Medical Device Correction letter dated 04/25/2022 was sent to customers with affected devices. The letter mentions the users can continue to use the ventilator while connected to an AC mains power source that is supported by backup emergency power. The letter provides a series of recommendations for the consignee to follow. The letter also requests that the consignee complete the medical device notification acknowledgement response form and send it back to the firm.
Recall number: Z-1285-2022

Field replacement back up batteries distributed on or after April 1…

Product: Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Quantity: 88,347 batteries
Codes and lots: Field Replacement Units (FRU) Battery kits - PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) or PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR), that may have been installed by the customer into any of the following anesthesia systems: o Avance 1009-9002-000 o Aespire View 1009-9212-000 o Avance CS2 and Avance CS2 Pro 1009-9050-000
Recall started: April 25, 2022
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Under Investigation by firm
What the company told customers: An Urgent Medical Device Correction letter dated 04/25/2022 was sent to customers with affected devices. The letter mentions the users can continue to use the ventilator while connected to an AC mains power source that is supported by backup emergency power. The letter provides a series of recommendations for the consignee to follow. The letter also requests that the consignee complete the medical device notification acknowledgement response form and send it back to the firm.
Recall number: Z-1286-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1285-2022, Z-1286-2022. The agency record governs; check it and the company before acting.

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