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FDAFDA · Food and drugs·Recall number Z-1285-2022

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019

Published July 6, 2022 · Recall initiated: April 25, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Backup batteries can fail earlier than their estimated life.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare, LLC
Distributor
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.
Lot
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, APKA
Risk classification
Class II
Area (FDA)
device
Country
United States

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