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U.S. Department of Health and Human Services

Class 1 Device Recall NIM Vital Nerve Integrity Monitor

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 Class 1 Device Recall NIM Vital Nerve Integrity Monitorsee related information
Date Initiated by FirmJune 24, 2024
Date PostedJuly 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2409-2024
Recall Event ID 94876
510(K)NumberK200759 
Product Classification Stimulator, electrical, evoked response - Product Code GWF
ProductNIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
Code Information All serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. Product Number; GTIN Number (Lot Number): 1. Product Number: NIM4CM01; GTIN Number (Lot Number): 00763000002978 (1850076, 1850079, 1850082, 1850083, 1850093, 1850095, C1915008, C1915009, C1915012, C1915013, C1915014, C1915015, C1915018, C1915020, C1915022, C1915025, C1915027, C1915028, C1915030, C1915031, C1915032, C1915038, C1915039, C1915040, C1915042, C1915048, C1915053, C1915057, C1915061, C1915062, C1915063, C1915064, C1915065, C1915066, C1915068, C1915069, C1915070, C1915072, C1915073, C1915074, C1915075, C1915077, C1915080, C1915085, C1915089, C1915090, C1915094, C1915096, C1915098, C1915102, C1915103, C1915104, C1915105, C1915106, C1915107, C1915108, C1915109, C1915110, C1915116, C1915119, C1915121, C1915124, C1915127, C1915129, C1915130, C1915131, C1915152, C1915153, C1915157, C1915158, C1915160, C1915161, C1915165, C1915166, C1915168, C1915175, C1915176, C1915177, C1915179, C1915180, C1915183, C1915184, C1915185, C1915186, C1915188, C1915215, C1915216), 00763000395896 (C2026001, C2026004, C2026006, C2026008, C2026010, 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C2110090, C2110091, C2110092, C2110093, C2110094, C2110095, C2110099, C2110100, C2110101, C2110102, C2110103, C2110104, C2110105, C2110106, C2110107, C2110108, C2110109, C2110119, C2110120, C2110121, C2110123, C2110124, C2110125, C2110126, C2110127, C2110128, C2110129, C2110130, C2110131, C2110132, C2110135, C2110136, C2110137, C2110138, C2110139, C2110140, C2110141, C2110142, C2110143, C2110144, C2110145, C2110146, C2110147, C2110148, C2110149, C2110150, C2110151, C2110152, C2110153, C2110154, C2110155, C2110156, C2110158, C2110159, C2110161, C2110162, C2110163, C2110165, C2110166, C2110167, C2110168, C2110169, C2110170, C2110171, C2110172, C2110173, C2110174, C2110175, C2110176, C2110177, C2110180, C2110181, C2110182, C2110183, C2110184, C2110185, C2110186, C2110187, C2110188, C2110189, C2110190, C2110191, C2110192, C2110193, C2110194, C2110195, C2110196, C2110197, C2110199, C2110200, C2110201, C2110202, C2110203, C2110204, C2110205, C2110206, C2110207, C2110208, C2110209, C2110210, 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C2322226, C2322227, C2322228, C2322230, C2322231, C2322232, C2322234, C2322236, C2322237, C2322238, C2322239, C2322240, C2322241, C2322242, C2322243, C2322244, C2550008), 00763000401597 (C1915092, C1915147, C1915149, C1915150, C1915154, C1915162, C1915169, C1915170, C1915171, C1915172, C1915173, C1915174, C2026076, C2026077, C2026078, C2026079, C2026080, C2026081, C2026082, C2026083, C2026084, C2026085, C2026086, C2026087, C2026088, C2026089, C2026090, C2026091, C2026092, C2026093, C2026094, C2026096, C2026097, C2026098, C2026099, C2026100, C2026101, C2026102, C2026103, C2026104, C2026105, C2026106, C2026107, C2026108, C2026109, C2026114, C2026115, C2026116, C2026117, C2026118, C2026119, C2026120, C2026121, C2026122, C2026123, C2026124, C2026125, C2026126, C2026127, C2026128, C2026129, C2026130, C2026131, C2026132, C2026133, C2026148, C2026149, C2026150, C2026152, C2026153, C2026156, C2026158, C2026161, C2026162, C2026163, C2026164, C2026165, C2026166, C2026176, C2026177, C2026178, C2026182, C2026187, C2026188, C2026190, C2026191, C2026194, C2026195, C2110015, C2110016, C2110329, C2110330, C2110363, C2110364, C2110365, C2110366, C2110367, C2110368, C2110369, C2110370, C2110376, C2110377, C2110378, C2110427, C2110431, C2110432, C2110433, C2110434, C2110435, C2148090, C2148091, C2148113, C2148115, C2148123, C2148124, C2148149, C2148150, C2148152, C2148166, C2148167, C2148168, C2148233, C2148281, C2148302, C2148348, C2148355, C2148366, C2148367, C2214030, C2214031, C2214033, C2214034, C2214035, C2214036, C2214063, C2214072, C2214076, C2214078, C2214115, C2214116, C2214141, C2214142, C2214143, C2214144, C2214156, C2214157, C2214170, C2214171, C2214172, C2214173, C2214191, C2214206, C2214235, C2214236, C2214237, C2214238, C2214279, C2214280, C2214281, C2214282, C2214283, C2214361, C2214362, C2214365, C2214366, C2214367, C2214368, C2214401, C2214402, C2214403, C2214404, C2214405, C2214422, C2214423, C2214424, C2214425, C2214426, C2214427, C2214457, C2214458, C2214459, C2214460, C2214461, C2214462, C2214463, C2214464, C2214465, C2214466, C2214481, C2214483, C2214484, C2214485, C2214486, C2214487, C2214488, C2214489, C2214490, C2214491, C2250243, C2250244, C2250246, C2250247, C2250248, C2250249, C2250250, C2250297, C2250299, C2250300, C2250301, C2250331, C2250332, C2250333, C2250334, C2250407, C2250408, C2250409, C2250410, C2250411, C2250416, C2250419, C2250422, C2250423, C2250424, C2250437, C2250440, C2250441, C2250442, C2250443, C2250444, C2250445, C2250446, C2250447, C2250448, C2250449, C2250454, C2314238, C2314245, C2314246, C2314247, C2314248, C2314249, C2314250, C2314251, C2314252, C2314372, C2314373, C2314374, C2314413, C2314414, C2314415, C2314416, C2314438, C2314468, C2314469, C2402017, C2402018, C2402019, C2402044, C2402047, C2402103, C2402104, C2402106, C2402107, C2402108, C2402109, C2402110, C2402114, C2402156, C2402157, C2402178, C2402179), 00763000528577 (C2314002, C2314003, C2314004, C2314005, C2314006, C2314007, C2314008, C2314009, C2314010, C2314011, C2314012, C2314013, C2314014, C2314015, C2314016, C2314019, C2314020, C2314021, C2314023, C2314024, C2314032, C2314033, C2314034, C2314035, C2314036, C2314037, C2314038, C2314040, C2314041, C2314042, C2314043, C2314044, C2314045, C2314046, C2314047, C2314048, C2314049, C2314050, C2314051, C2314052, C2314053, C2314054, C2314055, C2314056, C2314057, C2314058, C2314059, C2314060, C2314061, C2314062, C2314063, C2314064, C2314065, C2314066, C2314067, C2314068, C2314069, C2314070, C2314072, C2314074, C2314075, C2314076, C2314077, C2314078, C2314079, C2314080, C2314081, C2314082, C2314083, C2314084, C2314085, C2314086, C2314087, C2314088, C2314089, C2314090, C2314091, C2314092, C2314093, C2314094, C2314095, C2314096, C2314097, C2314098, C2314100, C2314101, C2314102, C2314103, C2314104, C2314106, C2314107, C2314108, C2314109, C2314110, C2314111, C2314112, C2314113, C2314114, C2314115, C2314117, C2314118, C2314119, C2314120, C2314122, C2314123, C2314124, C2314125, C2314126, C2314128, C2314129, C2314130, C2314131, C2314132, C2314133, C2314134, C2314135, C2314136, C2314137, C2314138, C2314139, C2314140, C2314141, C2314142, C2314143, C2314144, C2314145, C2314146, C2314147, C2314148, C2314149, C2314150, C2314151, C2314152, C2314153, C2314154, C2314155, C2314156, C2314157, C2314158, C2314159, C2314160, C2314161, C2314162, C2314163, C2314164, C2314165, C2314166, C2314167, C2314168, C2314169, C2314170, C2314171, C2314172, C2314173, C2314178, C2314179, C2314180, C2314181, C2314182, C2314183, C2314184, C2314185, C2314186, C2314187, C2314188, C2314189, C2314190, C2314191, C2314192, C2314193, C2314195, C2314196, C2314197, C2314198, C2314199, C2314200, C2314201, C2314202, C2314203, C2314204, C2314205, C2314206, C2314207, C2314208, C2314209, C2314210, C2314211, C2314212, C2314213, C2314214, C2314215, C2314216, C2314217, C2314218, C2314219, C2314220, C2314221, C2314222, C2314223, C2314225, C2314226, C2314227, C2314229, C2314230, C2314231, C2314232, C2314233, C2314234, C2314235, C2314236, C2314237, C2314239, C2314240, C2314241, C2314242, C2314243, C2314244, C2314253, C2314254, C2314255, C2314256, C2314257, C2314258, C2314259, C2314260, C2314261, C2314262, C2314263, C2314264, C2314265, C2314266, C2314267, C2314268, C2314269, C2314270, C2314271, C2314272, C2314273, C2314274, C2314275, C2314276, C2314277, C2314278, C2314279, C2314280, C2314281, C2314282, C2314283, C2314284, C2314285, C2314286, C2314287, C2314288, C2314289, C2314290, C2314291, C2314292, C2314293, C2314294, C2314295, C2314296, C2314297, C2314298, C2314299, C2314300, C2314302, C2314303, C2314304, C2314305, C2314306, C2314307, C2314308, C2314309, C2314310, C2314311, C2314312, C2314313, C2314314, C2314315, C2314316, C2314317, C2314318, C2314319, C2314320, C2314321, C2314322, C2314323, C2314324, C2314325, C2314327, C2314328, C2314329, C2314330, C2314331, C2314332, C2314334, C2314335, C2314336, C2314337, C2314338, C2314339, C2314340, C2314341, C2314342, C2314343, C2314344, C2314345, C2314346, C2314347, C2314348, C2314349, C2314350, C2314352, C2314353, C2314354, C2314355, C2314356, C2314357, C2314358, C2314359, C2314360, C2314361, C2314363, C2314364, C2314365, C2314367, C2314371, C2314375, C2314376, C2314377, C2314378, C2314380, C2314383, C2314384, C2314385, C2314386, C2314387, C2314389, C2314390, C2314391, C2314393, C2314394, C2314395, C2314396, C2314397, C2314398, C2314399, C2314400, C2314401, C2314402, C2314403, C2314404, C2314407, C2314408, C2314409, C2314417, C2314419, C2314420, C2314421, C2314422, C2314423, C2314424, C2314425, C2314426, C2314427, C2314428, C2314429, C2314430, C2314431, C2314432, C2314433, C2314434, C2314435, C2314436, C2314437, C2314439, C2314440, C2314441, C2314442, C2314443, C2314445, C2314446, C2314447, C2314448, C2314449, C2314451, C2314452, C2314453, C2314454, C2314455, C2314456, C2314458, C2314459, C2314460, C2314461, C2314462, C2314463, C2314465, C2314467, C2314470, C2314471, C2314472, C2314473, C2314474, C2314475, C2314476, C2314477, C2314478, C2314479, C2314480, C2314481, C2314482, C2314483, C2314484, C2314485, C2314486, C2314487, C2314488, C2314489, C2314490, C2314491, C2314492, C2314493, C2314496, C2314497, C2314499, C2314500, C2402001, C2402002, C2402003, C2402005, C2402006, C2402007, C2402008, C2402009, C2402010, C2402014, C2402015, C2402016, C2402020, C2402021, C2402022, C2402023, C2402024, C2402025, C2402026, C2402027, C2402028, C2402029, C2402030, C2402031, C2402032, C2402033, C2402034, C2402036, C2402037, C2402038, C2402040, C2402041, C2402042, C2402043, C2402046, C2402049, C2402050, C2402051, C2402052, C2402053, C2402054, C2402055, C2402056, C2402058, C2402059, C2402060, C2402061, C2402062, C2402063, C2402064, C2402066, C2402067, C2402068, C2402069, C2402070, C2402072, C2402075, C2402076, C2402077, C2402078, C2402079, C2402080, C2402081, C2402082, C2402083, C2402085, C2402086, C2402087, C2402089, C2402090, C2402091, C2402092, C2402093, C2402094, C2402097, C2402098, C2402099, C2402100, C2402101, C2402102, C2402105, C2402111, C2402112, C2402113, C2402116, C2402117, C2402119, C2402120, C2402121, C2402122, C2402123, C2402124, C2402125, C2402127, C2402130, C2402134, C2402136, C2402137, C2402138, C2402139, C2402140, C2402141, C2402142, C2402143, C2402144, C2402147, C2402151, C2402153, C2402155, C2402158, C2402159, C2402174, C2402188, C2402200, C2402201, C2402202, C2402203, C2402204, C2402217, C2402218, C2402220, C2402221, C2402231, C2402232, C2402233, C2402238, C2402239, C2402240, C2402241, C2402242, C2402243, C2402244, C2402245, C2402246, C2402247, C2402248, C2402249, C2402250, C2402251, C2402252, C2402253, C2402254, C2402255, C2402256, C2402257, C2402258, C2402259, C2402260, C2402261, C2402262, C2402263, C2402264, C2402265, C2402266, C2402267, C2402268, C2402269, C2402270, C2402271, C2402272, C2402273, C2402274, C2402275, C2402276, C2402277, C2402278, C2402279, C2402280, C2402281, C2402282, C2402283, C2402284, C2402285, C2402286, C2402287, C2402288, C2402289, C2402290, C2402291, C2402292, C2402293, C2402294, C2402295, C2402296, C2402297, C2402298, C2402299, C2402300, C2402301, C2402302, C2402303, C2402304, C2402305, C2402306, C2402307, C2402308, C2402309, C2402310, C2402311, C2402312, C2402313, C2402314, C2402315, C2402316, C2402317, C2402318, C2402319, C2402320, C2402321, C2402322, C2402323, C2402324, C2402325, C2402326, C2402327, C2402346, C2402358, C2402365, C2402366, C2402367, C2402368, C2402369, C2402370, C2402371, C2402390, C2402391, C2402400, C2402401, C2402402, C2402405). 2. Product Number: NIM4CM01RF; GTIN Number: 00763000002992 (Lot Numbers: C1915118, C1915120, C1915126, C2026347, C2026475, C2110088, C2110098, C2110122, C2110160, C2110164, C2110178, C2110277, C2110322, C2110355, C2110373, C2148047, C2148073, C2148079, C2148181, C2148207, C2148401, C2148414, C2148459, C2148460, C2214049, C2214147, C2214252, C2214319, C2250089, C2250166, C2250221, C2250278, C2250280, C2250281, C2250418, C2250426, C2314116, C2314366, C2322054, C2322055, C2322056, C2322177). 3. Product Number: NIM4CPB1; GTIN Numbers (Lot Numbers): 00763000002985 (2008141, P1910178, P1910180, P1910181, P1910188, P1910192, P1910193, P1910196, P1910197, P1910203, P1910204, P1910205, P1910207, P1910208, P1910209, P1910210, P1910211, P1910228, P1910232, P1910254, P1910270, P1910274, P1910275, P1910277, P1910278, P1910279, P1910280, P1910281, P1910282, P1910283, P1910284, P1910290, P1910301, P1910304, P1910305, P1910309, P1910311, P1910314, P1910317, P1910326, P1910328, P1910336, P1910337, P1910339, P1910340, P1910346, P1910347, P1910349, P1910350, P1910351, P1910352, P1910353, P1910354, P1910355, P1910356, P1910357, P1910358, P1910359, P1910360, P1910364, P1910365, P1910367, P1910369, P1910370, P1910373, P1910374, P1910375, P1910376, P1910378, P1910380, P1910381, P1910383, P1910385, P1910386, P1910387, P1910389, P1910391, P1910392, P1910393, P1910394, P1910395, P1910397, P1910400, P1910401, P1910402, P1910403, P1910404, P1910405, P1910406, P1910407, P1910408, P1910412, P1910413, P1910414, P1910415, P1910418, P1910419, P1910421, P1910423, P1910424, P1910425, P1910426, P1910427, P1910428, P1910429, P1910430, P1910431, P1910432, P1910433, P1910434, P1910435, P1910436, P1910439, P1910440, P1910441, P1910447, P1910448, P1910449, P1910451, P1910452, P1910453, P1910455, P1910456, P1910457, P1910458, P1910459, P1910473, P1910474, P1910475, P1910476, P1910477, P1910478, P1910479, P1910480, P1910481, P1910482, P1910483, P1910484, P1910493, P1910494, P1910495, P1910496, P1910497, P1910498, P1910499, P1910500, P2008001, P2008002, P2008003, P2008004, P2008005, P2008007, P2008008, P2008011, P2008012, P2008013, P2008014, P2008015, P2008016, P2008017, P2008018, P2008021, P2008022, P2008023, P2008025, P2008026, P2008027, P2008030, P2008031, P2008032, P2008033, P2008034, P2008036, P2008037, P2008039, P2008040, P2008041, P2008042, P2008048, P2008049, P2008050, P2008052, P2008053, P2008054, P2008055, P2008056, P2008057, P2008058, P2008059, P2008066, P2008067, P2008071, P2008072, P2008073, P2008074, P2008075, P2008076, P2008077, P2008078, P2008079, P2008080, P2008081, P2008082, P2008084, P2008085, P2008088, P2008093, P2008110, P2008111, P2008112, P2008113, P2008114, P2008115, P2008116, P2008121, P2008124, P2008126, P2008127, P2008128, P2008129, P2008131, P2008132, P2008135, P2008137, P2026181, P2314161), 00763000401603 (P1910167, P1910169, P1910174, P1910183, P1910186, P1910190, P1910191, P1910217, P1910222, P1910225, P1910226, P1910460, P1910461, P1910462, P1910463, P1910464, P1910465, P1910466, P1910467, P1910468, P1910469, P1910470, P1910471, P1910472, P2026064, P2026065, P2026066, P2026067, P2026068, P2026069, P2026070, P2026071, P2026072, P2026073, P2026101, P2026102, P2026103, P2026104, P2026105, P2026106, P2026108, P2026109, P2026110, P2026111, P2026113, P2026114, P2026115, P2026116, P2026117, P2026118, P2026119, P2026120, P2026121, P2026123, P2026124, P2026125, P2026126, P2026127, P2026128, P2026129, P2026130, P2026131, P2026132, P2026133, P2026134, P2026135, P2026136, P2026138, P2026139, P2026140, P2026141, P2026143, P2026144, P2026146, P2026148, P2026149, P2026150, P2026151, P2026152, P2026154, P2026158, P2026159, P2026160, P2026228, P2026229, P2026230, P2026231, P2026232, P2026248, P2026249, P2026250, P2026251, P2026252, P2026253, P2026254, P2026255, P2026286, P2026287, P2026288, P2026289, P2026352, P2026734, P2026735, P2026736, P2026737, P2026738, P2026739, P2026759, P2026760, P2026818, P2026820, P2026821, P2127210, P2127211, P2127212, P2127213, P2127214, P2127215, P2127216, P2127217, P2127218, P2127219, P2127220, P2127221, P2127281, P2127282, P2127284, P2127285, P2127286, P2127287, P2127288, P2127540, P2127541, P2127568, P2127569, P2127578, P2127579, P2127612, P2127613, P2127614, P2127641, P2127643, P2127722, P2127769, P2127792, P2127841, P2127850, P2214040, P2214041, P2214042, P2214043, P2214045, P2214046, P2214067, P2214103, P2214104, P2214137, P2214138, P2214139, P2214140, P2214153, P2214154, P2214179, P2214180, P2214181, P2214182, P2214183, P2214184, P2214224, P2214225, P2214226, P2214227, P2214284, P2214287, P2214288, P2214289, P2214366, P2214367, P2214368, P2214369, P2214371, P2214513, P2214539, P2214571, P2214572, P2214573, P2214574, P2214575, P2214617, P2214618, P2214619, P2214621, P2214650, P2214651, P2214653, P2214654, P2214655, P2214701, P2214702, P2214703, P2214704, P2214705, P2214706, P2214707, P2214708, P2214709, P2214710, P2214744, P2214745, P2214746, P2214747, P2214748, P2214749, P2214750, P2214752, P2214753, P2214754, P2215170, P2215171, P2215172, P2215173, P2215174, P2215175, P2215176, P2215177, P2215181, P2215236, P2215237, P2215239, P2215241, P2215304, P2215305, P2215306, P2215307, P2215345, P2215356, P2215368, P2215369, P2215370, P2215371, P2215372, P2215373, P2314020, P2314021, P2314022, P2314023, P2314024, P2314025, P2314026, P2314027, P2314028, P2314029, P2314030, P2314031, P2314032, P2314033, P2314035, P2314036, P2314037, P2314039, P2314040, P2314041, P2314108, P2347113, P2347114, P2347115, P2347116, P2347117, P2347118, P2402064, P2408093, P2408097, P2408121, P2408122, P2408123, P2408124, P2408125, P2408126, P2408127, P2408128, P2408129, P2408130, P2408131, P2408132, P2408133, P2408134), 00763000395902 (P2026002, P2026003, P2026004, P2026005, P2026007, P2026008, P2026009, P2026010, P2026011, P2026012, P2026013, P2026016, P2026017, P2026019, P2026021, P2026022, P2026023, P2026024, P2026025, P2026026, P2026027, P2026028, P2026030, P2026031, P2026033, P2026034, P2026035, P2026037, P2026038, P2026039, P2026040, P2026041, P2026043, P2026044, P2026045, P2026047, P2026048, P2026049, P2026051, P2026052, P2026053, P2026054, P2026055, P2026058, P2026059, P2026060, P2026061, P2026062, P2026063, P2026074, P2026075, P2026076, P2026077, P2026078, P2026079, P2026081, P2026082, P2026083, P2026084, P2026085, P2026086, P2026087, P2026089, P2026090, P2026091, P2026092, P2026093, P2026094, P2026095, P2026096, P2026097, P2026098, P2026099, P2026107, P2026122, P2026153, P2026156, P2026161, P2026163, P2026166, P2026167, P2026168, P2026170, P2026171, P2026174, P2026175, P2026176, P2026177, P2026178, P2026180, P2026182, P2026183, P2026184, P2026185, P2026188, P2026191, P2026192, P2026198, P2026200, P2026201, P2026202, P2026206, P2026209, P2026210, P2026211, P2026212, P2026213, P2026214, P2026215, P2026216, P2026217, P2026218, P2026219, P2026220, P2026221, P2026222, P2026223, P2026224, P2026225, P2026227, P2026233, P2026234, P2026235, P2026236, P2026237, P2026243, P2026244, P2026245, P2026246, P2026256, P2026258, P2026259, P2026261, P2026262, P2026264, P2026265, P2026266, P2026267, P2026268, P2026270, P2026271, P2026272, P2026273, P2026274, P2026275, P2026276, P2026277, P2026278, P2026279, P2026280, P2026281, P2026282, P2026283, P2026284, P2026291, P2026292, P2026293, P2026295, P2026296, P2026297, P2026298, P2026299, P2026301, P2026302, P2026304, P2026305, P2026306, P2026307, P2026308, P2026309, P2026311, P2026312, P2026313, P2026314, P2026315, P2026316, P2026317, P2026318, P2026321, P2026323, P2026324, P2026326, P2026327, P2026328, P2026329, P2026330, P2026331, P2026332, P2026333, P2026334, P2026335, P2026336, P2026338, P2026339, P2026340, P2026341, P2026344, P2026347, P2026348, P2026349, P2026351, P2026353, P2026354, P2026356, P2026357, P2026358, P2026363, P2026364, P2026365, P2026366, P2026367, P2026368, P2026369, P2026370, P2026372, P2026373, P2026374, P2026376, P2026378, P2026379, P2026381, P2026382, P2026383, P2026384, P2026385, P2026386, P2026387, P2026388, P2026389, P2026404, P2026405, P2026406, P2026407, P2026408, P2026409, P2026410, P2026411, P2026412, P2026414, P2026417, P2026418, P2026419, P2026420, P2026421, P2026422, P2026423, P2026424, P2026425, P2026426, P2026427, P2026428, P2026429, P2026430, P2026431, P2026432, P2026433, P2026434, P2026435, P2026436, P2026437, P2026438, P2026439, P2026440, P2026441, P2026442, P2026443, P2026444, P2026445, P2026446, P2026447, P2026448, P2026449, P2026450, P2026453, P2026454, P2026455, P2026456, P2026457, P2026458, P2026459, P2026460, P2026461, P2026462, P2026463, P2026464, P2026465, P2026466, P2026467, P2026468, P2026469, P2026472, P2026473, P2026474, P2026476, P2026477, P2026478, P2026479, P2026480, P2026481, P2026483, P2026492, P2026493, P2026494, P2026495, P2026496, P2026498, P2026500, P2026501, P2026502, P2026503, P2026504, P2026505, P2026506, P2026507, P2026508, P2026509, P2026510, P2026511, P2026512, P2026513, P2026514, P2026515, P2026516, P2026517, P2026518, P2026521, P2026522, P2026523, P2026524, P2026525, P2026526, P2026527, P2026528, P2026529, P2026531, P2026532, P2026533, P2026534, P2026535, P2026536, P2026537, P2026538, P2026539, P2026540, P2026541, P2026542, P2026543, P2026544, P2026546, P2026547, P2026548, P2026549, P2026550, P2026551, P2026552, P2026553, P2026554, P2026555, P2026556, P2026557, P2026564, P2026565, P2026566, P2026567, P2026568, P2026571, P2026572, P2026573, P2026574, P2026575, P2026576, P2026577, P2026578, P2026579, P2026580, P2026581, P2026582, P2026583, P2026584, P2026585, P2026586, P2026587, P2026588, P2026589, P2026590, P2026591, P2026592, P2026593, P2026594, P2026595, P2026596, P2026597, P2026598, P2026599, P2026603, P2026604, P2026606, P2026607, P2026608, P2026611, P2026612, P2026613, P2026614, P2026615, P2026616, P2026617, P2026629, P2026630, P2026631, P2026632, P2026637, P2026638, P2026639, P2026640, P2026643, P2026644, P2026645, P2026646, P2026647, P2026648, P2026649, P2026650, P2026651, P2026652, P2026653, P2026654, P2026655, P2026656, P2026657, P2026658, P2026660, P2026661, P2026662, P2026663, P2026664, P2026665, P2026666, P2026667, P2026669, P2026672, P2026673, P2026674, P2026675, P2026676, P2026677, P2026678, P2026679, P2026680, P2026681, P2026682, P2026686, P2026687, P2026688, P2026689, P2026690, P2026692, P2026693, P2026694, P2026695, P2026696, P2026697, P2026698, P2026705, P2026706, P2026707, P2026708, P2026709, P2026710, P2026712, P2026713, P2026715, P2026716, P2026718, P2026719, P2026720, P2026721, P2026722, P2026724, P2026725, P2026727, P2026729, P2026730, P2026732, P2026733, P2026740, P2026741, P2026742, P2026743, P2026744, P2026745, P2026746, P2026747, P2026748, P2026750, P2026751, P2026752, P2026753, P2026754, P2026755, P2026756, P2026757, P2026758, P2026762, P2026763, P2026764, P2026765, P2026773, P2026774, P2026775, P2026776, P2026777, P2026778, P2026779, P2026780, P2026781, P2026782, P2026783, P2026784, P2026785, P2026786, P2026787, P2026788, P2026789, P2026790, P2026791, P2026792, P2026793, P2026795, P2026797, P2026799, P2026801, P2026802, P2026803, P2026804, P2026805, P2026806, P2026807, P2026808, P2026809, P2026810, P2026811, P2026812, P2026813, P2026814, P2026815, P2026816, P2026817, P2026819, P2026822, P2026823, P2026824, P2026825, P2026826, P2026827, P2026828, P2026829, P2026830, P2026831, P2026832, P2026833, P2026834, P2026836, P2026837, P2026838, P2026839, P2026840, P2026841, P2026842, P2026843, P2026844, P2026845, P2026846, P2026847, P2026848, P2026849, P2026851, P2026852, P2026853, P2026859, P2026860, P2026861, P2026862, P2026863, P2026864, P2026865, P2026866, P2026867, P2026868, P2026869, P2026870, P2026871, P2026872, P2026873, P2026874, P2026875, P2026876, P2026877, P2026879, P2026880, P2026881, P2026882, P2026883, P2026884, P2026887, P2026888, P2026889, P2026890, P2026891, P2026892, P2026893, P2026894, P2026895, P2026898, P2026899, P2026900, P2026901, P2026902, P2026903, P2026904, P2026905, P2026906, P2026907, P2026908, P2026909, P2026910, P2026911, P2026912, P2026913, P2026914, P2026915, P2026916, P2026917, P2026918, P2026919, P2026920, P2026921, P2026922, P2026923, P2026924, P2026925, P2026926, P2026927, P2026928, P2026929, P2026930, P2026931, P2026932, P2026933, P2026934, P2026935, P2026936, P2026937, P2026938, P2026939, P2026940, P2026941, P2026944, P2026945, P2026947, P2026948, P2026949, P2026950, P2026951, P2026952, P2026953, P2026954, P2026955, P2026956, P2026957, P2026958, P2026959, P2026960, P2026961, P2026962, P2026963, P2026964, P2026965, P2026967, P2026968, P2026969, P2026970, P2026971, P2026972, P2026973, P2026975, P2026976, P2026977, P2026978, P2026979, P2026980, P2026981, P2026982, P2026983, P2026984, P2026985, P2026986, P2026987, P2026988, P2026989, P2026990, P2026992, P2026993, P2026994, P2026995, P2026996, P2026997, P2026998, P2026999, P2027000, P2127001, P2127002, P2127003, P2127004, P2127005, P2127006, P2127007, P2127008, P2127009, P2127010, P2127011, P2127012, P2127013, P2127014, P2127015, P2127016, P2127017, P2127018, P2127019, P2127020, P2127021, P2127022, P2127023, P2127024, P2127025, P2127026, P2127027, P2127028, P2127029, P2127030, P2127031, P2127032, P2127033, P2127034, P2127035, P2127036, P2127037, P2127038, P2127039, P2127040, P2127041, P2127042, P2127043, P2127044, P2127045, P2127046, P2127047, P2127048, P2127049, P2127050, P2127051, P2127054, P2127055, P2127056, P2127057, P2127058, P2127059, P2127060, P2127061, P2127062, P2127063, P2127064, P2127065, P2127066, P2127067, P2127068, P2127069, P2127070, P2127071, P2127072, P2127073, P2127074, P2127075, P2127076, P2127077, P2127078, P2127079, P2127081, P2127082, P2127083, P2127084, P2127085, P2127086, P2127087, P2127088, P2127089, P2127090, P2127091, P2127092, P2127093, P2127094, P2127095, P2127096, P2127097, P2127098, P2127099, P2127100, P2127101, P2127102, P2127103, P2127104, P2127105, P2127107, P2127108, P2127109, P2127110, P2127111, P2127112, P2127113, P2127114, P2127115, P2127116, P2127117, P2127118, P2127119, P2127120, P2127121, P2127122, P2127123, P2127124, P2127125, P2127126, P2127127, P2127128, P2127129, P2127130, P2127131, P2127132, P2127133, P2127134, P2127135, P2127136, P2127138, P2127139, P2127140, P2127141, P2127142, P2127143, P2127144, P2127145, P2127146, P2127147, P2127148, P2127149, P2127150, P2127151, P2127153, P2127154, P2127155, P2127156, P2127157, P2127158, P2127159, P2127160, P2127161, P2127162, P2127163, P2127165, P2127166, P2127167, P2127168, P2127172, P2127173, P2127174, P2127175, P2127176, P2127177, P2127178, P2127179, P2127180, P2127181, P2127182, P2127183, P2127184, P2127186, P2127187, P2127188, P2127189, P2127190, P2127191, P2127192, P2127193, P2127194, P2127195, P2127196, P2127197, P2127198, P2127199, P2127200, P2127201, P2127202, P2127203, P2127204, P2127205, P2127206, P2127207, P2127209, P2127222, P2127223, P2127224, P2127226, P2127227, P2127228, P2127229, P2127230, P2127231, P2127232, P2127233, P2127234, P2127235, P2127236, P2127237, P2127239, P2127240, P2127241, P2127242, P2127243, P2127244, P2127245, P2127246, P2127247, P2127248, P2127249, P2127250, P2127251, P2127252, P2127253, P2127254, P2127255, P2127256, P2127257, P2127258, P2127259, P2127260, P2127261, P2127262, P2127263, P2127264, P2127265, P2127266, P2127267, P2127268, P2127269, P2127270, P2127271, P2127272, P2127275, P2127276, P2127277, P2127278, P2127279, P2127280, P2127283, P2127289, P2127290, P2127291, P2127292, P2127294, P2127295, P2127298, P2127299, P2127302, P2127303, P2127304, P2127305, P2127307, P2127308, P2127309, P2127310, P2127311, P2127312, P2127313, P2127314, P2127317, P2127318, P2127319, P2127321, P2127322, P2127323, P2127324, P2127325, P2127326, P2127327, P2127328, P2127329, P2127330, P2127331, P2127332, P2127333, P2127334, P2127336, P2127337, P2127338, P2127339, P2127340, P2127341, P2127342, P2127343, P2127344, P2127345, P2127346, P2127348, P2127349, P2127350, P2127351, P2127352, P2127353, P2127355, P2127356, P2127357, P2127358, P2127359, P2127360, P2127361, P2127362, P2127363, P2127364, P2127365, P2127366, P2127367, P2127368, P2127369, P2127370, P2127371, P2127372, P2127373, P2127374, P2127375, P2127376, P2127377, P2127378, P2127379, P2127380, P2127381, P2127382, P2127383, P2127384, P2127385, P2127386, P2127387, P2127388, P2127389, P2127390, P2127391, P2127392, P2127393, P2127394, P2127395, P2127396, P2127397, P2127398, P2127399, P2127400, P2127401, P2127402, P2127403, P2127404, P2127405, P2127406, P2127407, P2127408, P2127409, P2127410, P2127411, P2127412, P2127413, P2127414, P2127415, P2127416, P2127419, P2127420, P2127421, P2127422, P2127423, P2127424, P2127425, P2127427, P2127429, P2127430, P2127431, P2127432, P2127433, P2127434, P2127435, P2127436, P2127437, P2127438, P2127439, P2127440, P2127441, P2127442, P2127443, P2127445, P2127446, P2127447, P2127448, P2127449, P2127450, P2127451, P2127452, P2127453, P2127454, P2127455, P2127456, P2127457, P2127458, P2127459, P2127460, P2127461, P2127462, P2127463, P2127464, P2127465, P2127466, P2127467, P2127468, P2127469, P2127470, P2127471, P2127472, P2127473, P2127474, P2127477, P2127478, P2127479, P2127480, P2127481, P2127482, P2127483, P2127484, P2127485, P2127486, P2127487, P2127488, P2127489, P2127490, P2127491, P2127492, P2127493, P2127494, P2127495, P2127496, P2127497, P2127498, P2127499, P2127504, P2127505, P2127506, P2127507, P2127508, P2127509, P2127510, P2127511, P2127512, P2127513, P2127514, P2127515, P2127516, P2127517, P2127518, P2127519, P2127520, P2127521, P2127522, P2127523, P2127524, P2127525, P2127526, P2127528, P2127529, P2127530, P2127531, P2127532, P2127534, P2127535, P2127536, P2127537, P2127538, P2127539, P2127542, P2127543, P2127544, P2127545, P2127546, P2127547, P2127548, P2127549, P2127550, P2127552, P2127553, P2127555, P2127556, P2127557, P2127560, P2127561, P2127562, P2127563, P2127564, P2127565, P2127566, P2127567, P2127570, P2127571, P2127572, P2127573, P2127574, P2127575, P2127576, P2127577, P2127580, P2127581, P2127582, P2127583, P2127584, P2127585, P2127586, P2127587, P2127589, P2127591, P2127593, P2127594, P2127595, P2127596, P2127599, P2127600, P2127601, P2127602, P2127603, P2127604, P2127605, P2127606, P2127607, P2127608, P2127609, P2127610, P2127611, P2127615, P2127616, P2127617, P2127618, P2127619, P2127620, P2127621, P2127622, P2127623, P2127624, P2127625, P2127626, P2127627, P2127628, P2127629, P2127630, P2127631, P2127632, P2127633, P2127634, P2127635, P2127636, P2127637, P2127639, P2127640, P2127644, P2127645, P2127646, P2127648, P2127649, P2127650, P2127651, P2127652, P2127653, P2127654, P2127655, P2127656, P2127657, P2127658, P2127659, P2127660, P2127661, P2127662, P2127663, P2127666, P2127667, P2127668, P2127669, P2127670, P2127671, P2127672, P2127673, P2127674, P2127675, P2127676, P2127677, P2127678, P2127679, P2127680, P2127681, P2127683, P2127684, P2127685, P2127686, P2127688, P2127689, P2127690, P2127691, P2127692, P2127693, P2127694, P2127695, P2127696, P2127697, P2127698, P2127699, P2127700, P2127701, P2127702, P2127703, P2127704, P2127705, P2127706, P2127707, P2127708, P2127709, P2127711, P2127712, P2127713, P2127714, P2127715, P2127716, P2127717, P2127718, P2127719, P2127720, P2127721, P2127723, P2127724, P2127725, P2127726, P2127727, P2127728, P2127729, P2127730, P2127731, P2127733, P2127734, P2127735, P2127736, P2127737, P2127738, P2127739, P2127740, P2127742, P2127743, P2127744, P2127745, P2127746, P2127747, P2127748, P2127749, P2127750, P2127751, P2127752, P2127753, P2127754, P2127755, P2127756, P2127757, P2127758, P2127759, P2127760, P2127761, P2127762, P2127764, P2127765, P2127766, P2127767, P2127768, P2127770, P2127771, P2127772, P2127773, P2127774, P2127775, P2127776, P2127777, P2127778, P2127779, P2127780, P2127781, P2127782, P2127785, P2127786, P2127787, P2127788, P2127789, P2127790, P2127791, P2127793, P2127795, P2127796, P2127797, P2127798, P2127799, P2127800, P2127801, P2127802, P2127803, P2127806, P2127809, P2127810, P2127811, P2127812, P2127813, P2127814, P2127815, P2127816, P2127817, P2127818, P2127819, P2127820, P2127821, P2127822, P2127823, P2127824, P2127825, P2127826, P2127827, P2127828, P2127829, P2127830, P2127831, P2127832, P2127834, P2127835, P2127836, P2127837, P2127838, P2127839, P2127840, P2127842, P2127843, P2127844, P2127845, P2127846, P2127847, P2127848, P2127849, P2127851, P2127852, P2127854, P2127855, P2127856, P2127857, P2127858, P2127859, P2127860, P2127861, P2127862, P2127863, P2127864, P2127865, P2127866, P2127867, P2127868, P2127869, P2127870, P2127871, P2127872, P2127873, P2127874, P2127875, P2127876, P2127877, P2127878, P2127879, P2127880, P2127881, P2127882, P2127883, P2127884, P2127885, P2127886, P2127887, P2127888, P2127889, P2127890, P2127891, P2127892, P2127893, P2127894, P2127895, P2127896, P2127897, P2127898, P2127899, P2127900, P2127901, P2127902, P2127903, P2127904, P2127905, P2127906, P2127907, P2127908, P2127909, P2127910, P2127911, P2127912, P2127913, P2127914, P2127915, P2127916, P2127917, P2127918, P2127919, P2127920, P2127921, P2127922, P2127923, P2127924, P2127925, P2127926, P2127927, P2127928, P2127929, P2127930, P2127931, P2127932, P2127933, P2127934, P2127935, P2127936, P2127937, P2127938, P2127939, P2127940, P2127941, P2127942, P2127943, P2127944, P2127945, P2127946, P2127947, P2127948, P2127949, P2127951, P2127953, P2127954, P2127955, P2127956, P2127957, P2127959, P2127961, P2127962, P2127963, P2127964, P2127965, P2127966, P2127967, P2127968, P2127969, P2127970, P2127971, P2127972, P2127973, P2127974, P2127976, P2127977, P2127978, P2127980, P2127981, P2127982, P2127983, P2127984, P2127985, P2127986, P2127987, P2127988, P2127989, P2127990, P2127991, P2127992, P2127993, P2127994, P2127995, P2127996, P2127997, P2127998, P2127999, P2128000, P2214001, P2214002, P2214003, P2214004, P2214005, P2214006, P2214007, P2214008, P2214009, P2214010, P2214011, P2214012, P2214013, P2214014, P2214016, P2214017, P2214018, P2214019, P2214020, P2214021, P2214022, P2214023, P2214024, P2214025, P2214026, P2214027, P2214028, P2214030, P2214031, P2214033, P2214034, P2214035, P2214036, P2214037, P2214038, P2214039, P2214044, P2214048, P2214049, P2214050, P2214051, P2214052, P2214053, P2214055, P2214056, P2214057, P2214060, P2214061, P2214062, P2214063, P2214064, P2214065, P2214066, P2214069, P2214074, P2214075, P2214076, P2214077, P2214078, P2214079, P2214080, P2214081, P2214082, P2214083, P2214084, P2214085, P2214086, P2214088, P2214089, P2214090, P2214091, P2214092, P2214093, P2214094, P2214095, P2214097, P2214098, P2214099, P2214100, P2214101, P2214102, P2214105, P2214107, P2214108, P2214109, P2214110, P2214112, P2214113, P2214114, P2214115, P2214116, P2214117, P2214119, P2214120, P2214121, P2214122, P2214124, P2214125, P2214126, P2214127, P2214128, P2214129, P2214130, P2214131, P2214132, P2214133, P2214134, P2214135, P2214142, P2214143, P2214144, P2214145, P2214146, P2214148, P2214149, P2214150, P2214152, P2214156, P2214159, P2214160, P2214161, P2214162, P2214163, P2214164, P2214165, P2214166, P2214167, P2214168, P2214169, P2214170, P2214171, P2214172, P2214173, P2214174, P2214175, P2214176, P2214177, P2214178, P2214186, P2214187, P2214188, P2214189, P2214190, P2214191, P2214192, P2214193, P2214194, P2214196, P2214197, P2214199, P2214200, P2214201, P2214202, P2214203, P2214204, P2214205, P2214206, P2214207, P2214208, P2214209, P2214210, P2214211, P2214212, P2214213, P2214214, P2214216, P2214218, P2214219, P2214220, P2214221, P2214222, P2214223, P2214228, P2214229, P2214231, P2214232, P2214233, P2214234, P2214235, P2214236, P2214237, P2214238, P2214239, P2214240, P2214241, P2214242, P2214243, P2214244, P2214245, P2214246, P2214247, P2214248, P2214249, P2214250, P2214251, P2214252, P2214253, P2214254, P2214255, P2214256, P2214257, P2214259, P2214260, P2214262, P2214263, P2214264, P2214265, P2214266, P2214267, P2214268, P2214269, P2214270, P2214271, P2214272, P2214273, P2214274, P2214276, P2214277, P2214278, P2214279, P2214280, P2214281, P2214282, P2214283, P2214286, P2214291, P2214292, P2214293, P2214294, P2214295, P2214296, P2214297, P2214298, P2214299, P2214300, P2214301, P2214303, P2214304, P2214306, P2214307, P2214308, P2214309, P2214310, P2214311, P2214312, P2214313, P2214315, P2214316, P2214317, P2214318, P2214319, P2214320, P2214321, P2214322, P2214324, P2214325, P2214326, P2214327, P2214328, P2214329, P2214330, P2214331, P2214332, P2214333, P2214334, P2214335, P2214336, P2214337, P2214338, P2214339, P2214340, P2214341, P2214342, P2214343, P2214344, P2214345, P2214347, P2214349, P2214352, P2214353, P2214354, P2214355, P2214356, P2214357, P2214358, P2214360, P2214361, P2214362, P2214363, P2214364, P2214365, P2214370, P2214372, P2214373, P2214374, P2214376, P2214378, P2214379, P2214380, P2214381, P2214382, P2214383, P2214384, P2214386, P2214387, P2214388, P2214389, P2214390, P2214392, P2214393, P2214394, P2214395, P2214396, P2214397, P2214398, P2214399, P2214400, P2214401, P2214402, P2214403, P2214404, P2214405, P2214406, P2214407, P2214408, P2214409, P2214411, P2214412, P2214413, P2214414, P2214415, P2214416, P2214418, P2214419, P2214420, P2214421, P2214422, P2214423, P2214426, P2214428, P2214429, P2214430, P2214431, P2214432, P2214433, P2214434, P2214435, P2214436, P2214437, P2214438, P2214439, P2214440, P2214441, P2214442, P2214443, P2214444, P2214445, P2214448, P2214449, P2214450, P2214451, P2214452, P2214453, P2214454, P2214455, P2214456, P2214457, P2214458, P2214459, P2214460, P2214461, P2214462, P2214463, P2214464, P2214465, P2214466, P2214467, P2214468, P2214469, P2214470, P2214471, P2214472, P2214473, P2214474, P2214475, P2214476, P2214477, P2214478, P2214479, P2214480, P2214481, P2214482, P2214483, P2214484, P2214485, P2214486, P2214487, P2214488, P2214489, P2214490, P2214491, P2214492, P2214493, P2214494, P2214495, P2214496, P2214497, P2214498, P2214499, P2214500, P2214501, P2214502, P2214503, P2214504, P2214505, P2214508, P2214510, P2214512, P2214517, P2214518, P2214519, P2214520, P2214521, P2214522, P2214523, P2214524, P2214525, P2214526, P2214527, P2214528, P2214531, P2214532, P2214533, P2214534, P2214535, P2214536, P2214537, P2214538, P2214541, P2214542, P2214543, P2214544, P2214545, P2214546, P2214548, P2214549, P2214551, P2214552, P2214553, P2214554, P2214555, P2214560, P2214561, P2214562, P2214563, P2214565, P2214566, P2214568, P2214569, P2214576, P2214577, P2214578, P2214579, P2214580, P2214581, P2214582, P2214583, P2214584, P2214585, P2214586, P2214587, P2214588, P2214589, P2214590, P2214591, P2214592, P2214593, P2214596, P2214597, P2214601, P2214602, P2214603, P2214604, P2214605, P2214606, P2214607, P2214608, P2214609, P2214610, P2214611, P2214612, P2214613, P2214614, P2214615, P2214616, P2214622, P2214623, P2214624, P2214625, P2214627, P2214630, P2214634, P2214635, P2214636, P2214637, P2214638, P2214640, P2214643, P2214644, P2214646, P2214647, P2214656, P2214657, P2214658, P2214659, P2214662, P2214663, P2214666, P2214667, P2214668, P2214669, P2214670, P2214671, P2214672, P2214673, P2214674, P2214675, P2214676, P2214677, P2214678, P2214679, P2214680, P2214681, P2214682, P2214684, P2214685, P2214686, P2214687, P2214688, P2214689, P2214690, P2214691, P2214695, P2214696, P2214697, P2214698, P2214699, P2214700, P2214711, P2214712, P2214713, P2214714, P2214715, P2214716, P2214717, P2214718, P2214719, P2214720, P2214721, P2214722, P2214723, P2214725, P2214726, P2214728, P2214729, P2214730, P2214731, P2214732, P2214733, P2214734, P2214735, P2214736, P2214737, P2214738, P2214739, P2214740, P2214741, P2214742, P2214743, P2214751, P2214755, P2214756, P2214757, P2214759, P2214760, P2214762, P2214763, P2214764, P2214766, P2214767, P2214768, P2214769, P2214770, P2214771, P2214772, P2214773, P2214774, P2214775, P2214776, P2214777, P2214779, P2214780, P2214781, P2214782, P2214783, P2214784, P2214786, P2214787, P2214788, P2214789, P2214790, P2214791, P2214792, P2214793, P2214794, P2214795, P2214796, P2214797, P2214798, P2214799, P2214800, P2214801, P2214803, P2214805, P2214806, P2214808, P2214809, P2214810, P2214811, P2214812, P2214813, P2214815, P2214816, P2214817, P2214818, P2214819, P2214820, P2214821, P2214822, P2214823, P2214824, P2214825, P2214827, P2214828, P2214829, P2214830, P2214831, P2214832, P2214833, P2214834, P2214835, P2214836, P2214837, P2214838, P2214839, P2214840, P2214841, P2214843, P2214844, P2214846, P2214847, P2214848, P2214849, P2214850, P2214851, P2214852, P2214853, P2214855, P2214856, P2214857, P2214858, P2214859, P2214860, P2214861, P2214863, P2214864, P2214865, P2214866, P2214867, P2214868, P2214869, P2214870, P2214871, P2214872, P2214873, P2214875, P2214876, P2214877, P2214878, P2214879, P2214880, P2214881, P2214882, P2214883, P2214884, P2214885, P2214886, P2214887, P2214888, P2214890, P2214891, P2214892, P2214893, P2214894, P2214895, P2214896, P2214897, P2214898, P2214899, P2214900, P2214901, P2214902, P2214903, P2214904, P2214905, P2214906, P2214908, P2214909, P2214910, P2214911, P2214912, P2214913, P2214916, P2214917, P2214918, P2214919, P2214920, P2214921, P2214922, P2214923, P2214924, P2214925, P2214926, P2214927, P2214928, P2214929, P2214930, P2214931, P2214932, P2214933, P2214934, P2214935, P2214936, P2214937, P2214938, P2214939, P2214940, P2214941, P2214942, P2214943, P2214944, P2214945, P2214946, P2214947, P2214948, P2214949, P2214950, P2214951, P2214952, P2214953, P2214954, P2214955, P2214956, P2214957, P2214958, P2214959, P2214961, P2214962, P2214963, P2214964, P2214965, P2214966, P2214967, P2214968, P2214969, P2214970, P2214971, P2214972, P2214973, P2214974, P2214975, P2214976, P2214977, P2214978, P2214980, P2214981, P2214982, P2214983, P2214984, P2214985, P2214986, P2214987, P2214988, P2214989, P2214990, P2214991, P2214992, P2214993, P2214994, P2214995, P2214996, P2214997, P2214998, P2214999, P2215000, P2215001, P2215002, P2215003, P2215004, P2215005, P2215006, P2215007, P2215008, P2215009, P2215010, P2215011, P2215012, P2215013, P2215014, P2215015, P2215016, P2215017, P2215018, P2215019, P2215020, P2215021, P2215022, P2215023, P2215024, P2215025, P2215026, P2215027, P2215029, P2215030, P2215031, P2215032, P2215033, P2215034, P2215035, P2215036, P2215037, P2215038, P2215040, P2215041, P2215042, P2215043, P2215044, P2215045, P2215046, P2215047, P2215048, P2215049, P2215050, P2215051, P2215052, P2215053, P2215054, P2215055, P2215056, P2215057, P2215058, P2215059, P2215061, P2215066, P2215067, P2215068, P2215069, P2215070, P2215071, P2215072, P2215073, P2215074, P2215075, P2215076, P2215077, P2215078, P2215079, P2215080, P2215081, P2215082, P2215083, P2215084, P2215085, P2215086, P2215087, P2215088, P2215089, P2215090, P2215091, P2215092, P2215093, P2215094, P2215095, P2215096, P2215097, P2215098, P2215099, P2215100, P2215101, P2215102, P2215103, P2215104, P2215106, P2215107, P2215108, P2215109, P2215110, P2215111, P2215112, P2215113, P2215114, P2215115, P2215116, P2215117, P2215118, P2215119, P2215120, P2215121, P2215122, P2215123, P2215124, P2215125, P2215126, P2215128, P2215129, P2215130, P2215131, P2215132, P2215133, P2215134, P2215135, P2215136, P2215137, P2215138, P2215139, P2215141, P2215142, P2215143, P2215144, P2215145, P2215146, P2215147, P2215148, P2215149, P2215152, P2215153, P2215157, P2215158, P2215159, P2215160, P2215161, P2215162, P2215165, P2215166, P2215168, P2215169, P2215178, P2215179, P2215180, P2215182, P2215183, P2215185, P2215189, P2215190, P2215194, P2215195, P2215198, P2215199, P2215200, P2215201, P2215204, P2215205, P2215206, P2215208, P2215209, P2215210, P2215216, P2215217, P2215218, P2215220, P2215221, P2215222, P2215223, P2215224, P2215225, P2215226, P2215230, P2215231, P2215232, P2215233, P2215235, P2215238, P2215240, P2215242, P2215243, P2215244, P2215245, P2215246, P2215247, P2215248, P2215249, P2215250, P2215251, P2215252, P2215253, P2215254, P2215255, P2215256, P2215257, P2215258, P2215261, P2215264, P2215265, P2215266, P2215267, P2215268, P2215269, P2215270, P2215271, P2215272, P2215273, P2215274, P2215275, P2215278, P2215279, P2215282, P2215284, P2215286, P2215288, P2215290, P2215291, P2215292, P2215293, P2215294, P2215295, P2215296, P2215297, P2215298, P2215299, P2215300, P2215301, P2215302, P2215303, P2215308, P2215309, P2215310, P2215311, P2215312, P2215314, P2215315, P2215316, P2215324, P2215325, P2215327, P2215328, P2215332, P2215333, P2215334, P2215335, P2215336, P2215337, P2215340, P2215341, P2215342, P2215343, P2215344, P2215346, P2215347, P2215350, P2215351, P2215352, P2215353, P2215354, P2215355, P2215357, P2215358, P2215359, P2215360, P2215361, P2215364, P2215366, P2215367, P2215376, P2215377, P2215381, P2215392, P2215394, P2215396, P2215397, P2215398, P2215399, P2215400, P2215401, P2215404, P2215405, P2215406, P2215407, P2215408, P2215410, P2215411, P2215412, P2215413, P2215414, P2215415, P2215416, P2215417, P2215418, P2215419, P2215420, P2215421, P2215426, P2215427, P2215428, P2215437, P2215438, P2215445, P2215446, P2314142, P2314143), 00763000528584 (P2314002, P2314003, P2314004, P2314006, P2314009, P2314010, P2314011, P2314012, P2314013, P2314014, P2314015, P2314016, P2314017, P2314018, P2314019, P2314038, P2314042, P2314043, P2314044, P2314045, P2314046, P2314047, P2314048, P2314049, P2314050, P2314051, P2314052, P2314053, P2314055, P2314056, P2314059, P2314060, P2314061, P2314062, P2314063, P2314064, P2314065, P2314067, P2314068, P2314069, P2314070, P2314071, P2314072, P2314073, P2314074, P2314075, P2314077, P2314078, P2314080, P2314082, P2314083, P2314086, P2314087, P2314088, P2314089, P2314090, P2314091, P2314092, P2314093, P2314094, P2314095, P2314096, P2314098, P2314099, P2314100, P2314101, P2314102, P2314104, P2314105, P2314106, P2314107, P2314109, P2314110, P2314111, P2314112, P2314113, P2314114, P2314115, P2314116, P2314119, P2314120, P2314121, P2314122, P2314123, P2314124, P2314125, P2314126, P2314127, P2314128, P2314129, P2314130, P2314131, P2314132, P2314133, P2314134, P2314135, P2314136, P2314137, P2314138, P2314139, P2314140, P2314141, P2314144, P2314145, P2314146, P2314147, P2314148, P2314149, P2314150, P2314151, P2314152, P2314153, P2314154, P2314155, P2314156, P2314157, P2314158, P2314159, P2314160, P2314162, P2314163, P2314164, P2314165, P2314169, P2314170, P2314174, P2314175, P2314177, P2314178, P2314179, P2314180, P2314181, P2314182, P2314184, P2314187, P2314188, P2314189, P2314190, P2314191, P2314192, P2314193, P2314194, P2314195, P2314196, P2314198, P2314199, P2314200, P2314201, P2314202, P2314203, P2314205, P2314206, P2314207, P2314208, P2314209, P2314210, P2314212, P2314213, P2314214, P2314215, P2314216, P2314217, P2314218, P2314219, P2314220, P2314221, P2314222, P2314223, P2314224, P2314225, P2314229, P2314230, P2314236, P2314237, P2314241, P2314242, P2314244, P2314245, P2314247, P2314248, P2314249, P2314250, P2314251, P2314252, P2314253, P2314254, P2314255, P2314256, P2314257, P2314258, P2314259, P2314260, P2314261, P2314262, P2314264, P2314265, P2314266, P2314267, P2314268, P2314269, P2314271, P2314273, P2314274, P2314275, P2314277, P2314278, P2314279, P2314280, P2314281, P2314283, P2314284, P2314285, P2314286, P2314287, P2314290, P2314291, P2314293, P2314295, P2314296, P2314298, P2314299, P2314300, P2314301, P2314302, P2314303, P2314304, P2314306, P2314307, P2314310, P2314311, P2314312, P2314313, P2314314, P2314315, P2314316, P2314317, P2314318, P2314319, P2314320, P2314321, P2314322, P2314323, P2314324, P2314325, P2314326, P2314328, P2314329, P2314330, P2314331, P2314332, P2314333, P2314334, P2314336, P2314337, P2314338, P2314339, P2314340, P2314341, P2314342, P2314343, P2314344, P2314347, P2314348, P2314349, P2314350, P2314351, P2314352, P2314353, P2314354, P2314355, P2314356, P2314357, P2314358, P2314359, P2314361, P2314362, P2314363, P2314364, P2314365, P2314366, P2314367, P2314368, P2314369, P2314370, P2314371, P2314372, P2314373, P2314374, P2314375, P2314376, P2314377, P2314378, P2314379, P2314380, P2314381, P2314382, P2314383, P2314384, P2314385, P2314386, P2314387, P2314388, P2314389, P2314390, P2314391, P2314392, P2314393, P2314394, P2314395, P2314396, P2314397, P2314398, P2314399, P2314400, P2314401, P2314402, P2314403, P2314404, P2314405, P2314406, P2314407, P2314408, P2314409, P2314411, P2314412, P2314413, P2314415, P2314416, P2314417, P2314418, P2314419, P2314420, P2314421, P2314422, P2314423, P2314424, P2314425, P2314426, P2314427, P2314428, P2314429, P2314430, P2314431, P2314432, P2314433, P2314436, P2314437, P2314438, P2314439, P2314440, P2314441, P2314442, P2314443, P2314445, P2314446, P2314447, P2314455, P2314456, P2314457, P2314461, P2314462, P2314463, P2314464, P2314465, P2314466, P2314470, P2314471, P2314472, P2314473, P2314474, P2314475, P2314476, P2314477, P2314478, P2314479, P2314480, P2314481, P2314482, P2314483, P2314484, P2314485, P2314486, P2314492, P2314493, P2314494, P2314495, P2314496, P2314497, P2314498, P2314499, P2314500, P2333001, P2333002, P2333003, P2333004, P2333006, P2333007, P2333008, P2333009, P2333010, P2333011, P2333012, P2333014, P2333015, P2333017, P2333018, P2333019, P2333020, P2333021, P2333022, P2333023, P2333025, P2333026, P2333027, P2333028, P2333029, P2333030, P2333033, P2333034, P2333035, P2333036, P2333037, P2333038, P2333039, P2333040, P2333041, P2333042, P2333043, P2333044, P2333047, P2333049, P2333050, P2333051, P2333053, P2333054, P2333056, P2333057, P2333058, P2333059, P2333060, P2333061, P2333062, P2333063, P2333065, P2333066, P2333068, P2333069, P2333070, P2333071, P2333072, P2333073, P2333074, P2333075, P2333076, P2333077, P2333079, P2333080, P2333081, P2333082, P2333083, P2333084, P2333085, P2333086, P2333087, P2333088, P2333089, P2333090, P2333091, P2333092, P2333094, P2333095, P2333097, P2333098, P2333099, P2333100, P2333101, P2333102, P2333104, P2333105, P2333106, P2333107, P2333108, P2333109, P2333110, P2333111, P2333112, P2333113, P2333115, P2333116, P2333118, P2333122, P2333123, P2333124, P2333125, P2333126, P2333127, P2333128, P2333129, P2333130, P2333131, P2333132, P2333133, P2333134, P2333135, P2333136, P2333137, P2333138, P2333139, P2333140, P2333146, P2333147, P2333148, P2333149, P2333150, P2333151, P2333152, P2333153, P2333154, P2333155, P2333156, P2333157, P2333158, P2333159, P2333160, P2333161, P2333162, P2333163, P2333164, P2333165, P2333166, P2333167, P2333168, P2333169, P2333170, P2333171, P2333172, P2333173, P2333174, P2333175, P2333176, P2333177, P2333178, P2333179, P2333180, P2333181, P2333182, P2333183, P2333184, P2333185, P2333186, P2333188, P2333189, P2333190, P2333191, P2333193, P2333194, P2333195, P2333196, P2333197, P2333198, P2333199, P2333200, P2333201, P2333202, P2333203, P2333204, P2333205, P2333206, P2333208, P2333209, P2333210, P2333211, P2333212, P2333213, P2333214, P2333215, P2333216, P2333217, P2333219, P2333220, P2333221, P2333222, P2333223, P2333224, P2333225, P2333226, P2333227, P2333228, P2333229, P2333230, P2333231, P2333232, P2333233, P2333235, P2333236, P2333237, P2333238, P2333239, P2333240, P2333241, P2333242, P2333243, P2333245, P2333246, P2333248, P2333249, P2333250, P2339001, P2339002, P2339003, P2339004, P2339005, P2339007, P2339008, P2339010, P2339011, P2339012, P2339021, P2339022, P2339025, P2339027, P2339028, P2339029, P2339030, P2339031, P2339032, P2339033, P2339035, P2339036, P2339037, P2339038, P2339039, P2339042, P2339043, P2339044, P2339045, P2339048, P2339049, P2339050, P2339051, P2339052, P2339053, P2339054, P2339056, P2339057, P2339058, P2339059, P2339060, P2339061, P2339062, P2339063, P2339064, P2339069, P2339070, P2339071, P2339072, P2339073, P2339074, P2339075, P2339076, P2339077, P2339078, P2339079, P2339080, P2339081, P2339082, P2339083, P2339084, P2339085, P2339086, P2339087, P2339088, P2339089, P2339098, P2339099, P2339101, P2339102, P2339104, P2339105, P2339106, P2339107, P2339108, P2339109, P2339110, P2339111, P2339112, P2339113, P2339114, P2339115, P2339118, P2339119, P2339120, P2339121, P2339122, P2339123, P2339124, P2339127, P2339128, P2339129, P2339130, P2339131, P2339132, P2339133, P2339135, P2339136, P2339137, P2339138, P2339139, P2339140, P2339141, P2339142, P2339143, P2339144, P2339145, P2339146, P2339147, P2339148, P2339149, P2339150, P2339151, P2339152, P2339153, P2339154, P2339155, P2339156, P2339157, P2339158, P2339159, P2339160, P2339161, P2339162, P2339163, P2339164, P2339165, P2339166, P2339167, P2339168, P2339170, P2339172, P2339173, P2339175, P2339176, P2339177, P2339178, P2339179, P2339180, P2339181, P2339182, P2339183, P2339184, P2339185, P2339186, P2339187, P2339188, P2339189, P2339190, P2339191, P2339192, P2339194, P2339195, P2339196, P2339197, P2339198, P2339199, P2339200, P2339201, P2339202, P2339203, P2339209, P2339210, P2339211, P2339212, P2339213, P2339214, P2339215, P2339216, P2339217, P2339218, P2339219, P2339220, P2339221, P2339222, P2339223, P2339224, P2339225, P2339226, P2339227, P2339228, P2339229, P2339230, P2339237, P2339238, P2339239, P2339240, P2339241, P2339242, P2339243, P2339244, P2339245, P2339246, P2347002, P2347003, P2347004, P2347005, P2347006, P2347007, P2347008, P2347009, P2347010, P2347012, P2347013, P2347014, P2347015, P2347016, P2347017, P2347018, P2347020, P2347021, P2347023, P2347024, P2347025, P2347026, P2347027, P2347029, P2347030, P2347031, P2347032, P2347035, P2347036, P2347037, P2347038, P2347039, P2347040, P2347041, P2347042, P2347043, P2347044, P2347045, P2347046, P2347047, P2347048, P2347049, P2347050, P2347051, P2347052, P2347053, P2347054, P2347055, P2347058, P2347059, P2347060, P2347061, P2347062, P2347063, P2347064, P2347065, P2347066, P2347068, P2347069, P2347071, P2347072, P2347073, P2347074, P2347075, P2347076, P2347077, P2347078, P2347079, P2347080, P2347082, P2347083, P2347084, P2347085, P2347086, P2347087, P2347089, P2347090, P2347091, P2347092, P2347093, P2347094, P2347095, P2347096, P2347097, P2347098, P2347100, P2347101, P2347102, P2347103, P2347104, P2347105, P2347107, P2347108, P2347112, P2347119, P2347120, P2347121, P2347122, P2347123, P2347124, P2347125, P2347126, P2347127, P2347129, P2347130, P2347131, P2347132, P2347133, P2347134, P2347135, P2347138, P2347139, P2347140, P2347141, P2347142, P2347143, P2347144, P2347145, P2347146, P2347147, P2347148, P2347149, P2347150, P2347151, P2347152, P2347153, P2347155, P2347156, P2347157, P2347158, P2347159, P2347160, P2347161, P2347162, P2347163, P2347165, P2347166, P2347167, P2347168, P2347172, P2347173, P2347174, P2347175, P2347176, P2347177, P2347178, P2347179, P2347180, P2347181, P2347182, P2347184, P2347189, P2347191, P2347192, P2347193, P2347194, P2347195, P2347196, P2347197, P2347198, P2347200, P2347201, P2347202, P2347203, P2347210, P2347211, P2347212, P2347213, P2347214, P2347215, P2347216, P2347217, P2347218, P2347220, P2347221, P2347222, P2347223, P2347224, P2347225, P2347226, P2347238, P2347244, P2347245, P2347246, P2402005, P2402006, P2402007, P2402008, P2402009, P2402010, P2402011, P2402012, P2402013, P2402014, P2402015, P2402017, P2402019, P2402020, P2402025, P2402033, P2402034, P2402057, P2402061, P2402065, P2402066, P2402067, P2402068, P2402069, P2402070, P2402071, P2402072, P2402074, P2402075, P2402076, P2402077, P2402078, P2402079, P2402080, P2402082, P2402083, P2402084, P2402085, P2402086, P2402087, P2402088, P2402092, P2402100, P2402107, P2402108, P2402109, P2402110, P2402111, P2402115, P2402117, P2402118, P2402119, P2402129, P2402130, P2402131, P2402132, P2402133, P2402134, P2402135, P2402138, P2402139, P2402140, P2402141, P2402142, P2402144, P2402145, P2402146, P2402153, P2402154, P2402155, P2402156, P2402157, P2402158, P2402159, P2402160, P2402161, P2402164, P2402165, P2402166, P2402167, P2402168, P2402170, P2402171, P2402172, P2402173, P2402174, P2402175, P2402176, P2402177, P2402178, P2402179, P2402180, P2402181, P2402182, P2402183, P2402184, P2402185, P2402186, P2402187, P2402188, P2402189, P2402190, P2402193, P2402194, P2402195, P2402196, P2402197, P2402198, P2402199, P2402201, P2402202, P2402203, P2408002, P2408003, P2408004, P2408015, P2408021, P2408024, P2408033, P2408038, P2408042, P2408043, P2408044, P2408045, P2408047, P2408050, P2408052, P2408056, P2408057, P2408058, P2408059, P2408060, P2408061, P2408062, P2408063, P2408064, P2408068, P2408069, P2408070, P2408074, P2408075, P2408076, P2408077, P2408078, P2408079, P2408080, P2408081, P2408082, P2408083, P2408084, P2408085, P2408086, P2408087, P2408088, P2408090, P2408095, P2408101, P2408104, P2408106, P2408107, P2408113, P2408114, P2408115, P2408116, P2408117, P2408118, P2408119, P2408135, P2408136, P2408137, P2408138, P2408139, P2408140, P2408141, P2408142, P2408143, P2408144, P2408145, P2408156, P2408157, P2408158, P2408159, P2408160, P2408161, P2408162, P2408163, P2408164, P2408167, P2408168, P2408169, P2408170, P2408182, P2408196, P2408198, P2408200, P2408203, P2408204, P2408205, P2408206, P2408207, P2408208, P2408209, P2408210, P2408211, P2408212, P2408213, P2408214, P2408215, P2408216, P2408217, P2408218, P2408219, P2408220, P2408221, P2408222, P2408223, P2408224, P2408225, P2408226, P2408227, P2408228, P2408229, P2408230, P2408231, P2408232, P2408233, P2408234, P2408236, P2408237, P2408238, P2408239, P2408240, P2408241, P2408242, P2408243, P2408244, P2408245, P2408246, P2408247, P2408248, P2408249, P2408250, P2410033, P2410034, P2410035, P2410036, P2410037, P2410038, P2410039, P2410040, P2410041, P2410042, P2410043, P2410044, P2410045, P2410046, P2410048, P2410049, P2410050, P2410051, P2410052, P2410053, P2410054, P2410055, P2410056, P2410057, P2410058, P2410059, P2410060, P2410061, P2410062, P2410063, P2410064, P2410065, P2410066, P2410067, P2410068, P2410069, P2410070, P2410071, P2410072, P2410073, P2410074, P2410075, P2410076, P2410077, P2410078, P2410079, P2410080, P2410081, P2410082, P2410083, P2410084, P2410085, P2410086, P2410087, P2410088, P2410089, P2410090, P2410091, P2410092, P2410093, P2410094, P2410095, P2410096, P2410098, P2410100, P2410101, P2410102, P2410127, P2410128, P2410129, P2410130, P2410131, P2410132, P2410133, P2410134, P2410135, P2410136, P2410137, P2410138, P2410139, P2410140, P2410141, P2410142, P2410143, P2410144, P2410145, P2410146, P2410147, P2410148, P2410150, P2410151, P2410152, P2410153, P2410154, P2410155, P2410156, P2410158, P2410159, P2410160, P2410162, P2410163, P2410180, P2410181, P2410182, P2410183, P2410184, P2410217, P2410218, P2410219, P2410222, P2410223, P2410224, P2410225, P2410226, P2410232, P2410233). 4. Product Number: NIM4CPB1RF; GTIN Number: 00763000003005 (Lot Numbers: RP2018002, RP2018003, RP2018005, RP2018006, RP2018008, RP2018009, RP2018010, RP2018011, RP2018012, RP2018013, RP2018015, RP2018016, RP2018017, RP2018022, RP2018023, RP2018025, RP2018026, RP2018027, RP2018030, RP2018032, RP2018036, RP2018037, RP2018039, RP2018040, RP2018041, RP2018042, RP2018043, RP2018044, RP2018047, RP2018048, RP2018049, RP2018050, RP2018051, RP2018052, RP2018053, RP2018054, RP2018055, RP2018057, RP2018100). 5. Product Number: NIM4SWU143; GTIN Numbers: 00763000709341 (Lot Numbers: 0226074760, 0226076883, 0226086936, 0226086936, 0226096411), 00763000869823 (Lot Number: 0226086936.
Recalling Firm/
Manufacturer
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information ContactMarie Gentile
404-693-6028
Manufacturer Reason
for Recall
Potential for false negative response on the NIM Vital Nerve Monitoring System
FDA Determined
Cause 2
Under Investigation by firm
ActionMedtronic Xomed notified consignees on 06/24/2024 via letter. The letter instructed consignees that Medtronic has developed a NIM" Vital software version 1.5.4 to address this issue. Consignees were also instructed to identify affected products within inventory, share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action, and maintain a copy of this letter for your records. The respective Medtronic Representative will contact you to install the new software version 1.5.4 for correction of the impacted product in your possession. Additionally, consignees were asked to complete and return the customer confirmation form enclosed via email to neuro.quality@medtronic.com. Medtronic Xomed sent consignees a follow up letter with updated information on 08/22/2024. The update provided additional information and instructions to mitigate the risk with affected devices.
Quantity in Commerce7,804 units
DistributionWorldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GWF
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