FDAFDA · Alimentos y medicamentos·N.º oficial Z-1285-2022
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Publicado el 6 de julio de 2022 · Inicio del retiro: 25 de abril de 2022
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Backup batteries can fail earlier than their estimated life.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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