Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

Recall details

Manufacturer

DKK Dai-Ichi Shomei Co., Ltd.

Distributor

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

Lot

Model Number: LED7-LH/7TV-LH; Serial Numbers: 7010002, 7010003, 7010004, 7010005, 7010006, 7030007, 7030008, 7030009, 7030010, 7030011, 7030012, 7030013, 7030014, 7030015, 7030016, 7030017, 7030018, 7030019, 7030020, 7030021, 7040022, 7040023, 7040024, 7040025, 7040026, 7040027, 7040028, 7040029, 7040030, 7040031, 7040032, 7040033, 7040034, 7040035, 7040036, 7040037, 7070039, 7070040, 7070041, 7070042, 7070043, 7070044, 7070045, 7070046, 7070047, 7070048, 7070049, 7070050, 7080053, 7080054, 7080055, 7080056, 7080057, 7080058, 7080059, 7080060, 07080061, 7080062, 7080063, 7080064, 7080065, 7080066, 7080067, 7080068, 7080069, 7080070, 7080071, 7080072, 7080073, 7080074, 7080075, 7080076, 7080077, 7080078, 7080079, 7080080, 7080081, 7090082, 7090083, 7090084, 7090085, 7090086, 7090087, 7090088, 7090089, 7090090, 7090091, 7100092, 7100093, 7100094, 7100095, 7100096, 7100097, 07100098, 7100099, 7100100, 7100101, 7100102, 7100103, 7100104, 7100105, 7100106, 7100107, 7100108, 7100109, 7100110, 7100111, 7110112, 7110113, 7110114, 7110115, 7110116, 7110117, 7110118, 7110119, 7110120, 7110121, 7110122, 7110123, 7110124, 7110125, 7110126, 7110127, 7110128, 7110129, 7110130, 7110131, 7120132, 8010134, 8010135, 8010136, 8010137, 8010138, 8010139, 8010140, 8010141, 8010142, 8010143, 8010144, 8010145, 8010146, 8010147, 8010148, 8010149, 8010150, 8010151, 8010152, 8020153, 8020154, 8020155, 8020156, 8020157, 8020158, 8020159, 8020160, 8020161, 8020162, 8020163, 8020164, 8020165, 8020166, 8020167, 8020168, 8020169, 08020170, 08020171, 08020172, 8020173, 8020174, 8020175, 8020176, 8020177, 8020178, 8020179, 8020180, 8020181, 8020182, 8020183, 8020184, 8020185, 8020186, 8020187, 8020188, 8020189, 8020190, 8020191, 8020192, 8020193, 08020194, 8030195, 8030196, 8030197, 8030198, 8030199, 8030200, 8030201, 8030202, 8030203, 8030204, 8030205, 8030206, 8030207, 8030208, 8030209, 8030210, 8030211, 8030212, 8030213, 8030214, 8030215, 8030216, 8030217, 8030218, 8030219, 8030220, 8030221, 8030222, 8030223, 8030224, 8040225, 8040226, 8040227, 8040228, 8040229, 8040230, 8040231, 8040232, 8040233, 8040234, 8040235, 8040236, 8040237, 8040238, 8040239, 8040240, 8040241, 8040242, 8040243, 8040244, 8040245, 8040246, 8040247, 8050248, 8050249, 8050250, 8050251, 8050252, 8050253, 8050254, 8050255, 8050256, 8050257, 8050258, 8050259, 8050260, 8050261, 8050262, 8050263, 8050264, 8050290, 8050291, 8050292, 8050293, 8050294, 8050295, 8050296, 8050297, 8050298, 8050299, 8050300, 8070301, 8070302, 8070303, 8070304, 8070305, 8070306, 8070307, 8070308, 8070309, 8070310, 8070311, 8070312, 8070313, 8070314, 8070315, 8070316, 8070317, 8070318, 8070319, 8070320, 8080321, 8080322, 8080323, 8080324, 8080325, 8080326, 8080327, 8080328, 8080329, 8080330, 8080331, 8080332, 8080333, 8080334, 8080335, 8080336, 8080337, 8080338, 8080339, 8080340, 8080341, 8080342, 8080343, 8080344, 8080345, 8080346, 8080347, 8080348, 8080349, 8080350, 8090351, 8090352, 8090353, 8090354, 8090355, 8090356, 8090357, 8090358, 8090359, 8090360, 8090361, 8090362, 8090363, 8090364, 8090365, 8100366, 8100367, 8100368, 8100369, 8100370, 8100371, 8100372, 8100373, 8100374, 8100375, 8100376, 8100377, 8100378, 8100379, 8100380, 8100381, 8100382, 8100383, 8100384, 8100385, 8100386, 8100387, 8100388, 8100389, 8100390, 8100391, 8100392, 8100393, 8100394, 8100395, 8100396, 8100397, 8100398, 8110400, 8110401, 8110402, 8110403, 8110404, 8110405, 8110406, 8110407, 8110408, 8120409, 8120410, 8120411, 8120412, 8120413, 8120414, 8120415, 8120416, 8120417, 8120418, 8120419, 8120420, 8120421, 08120422, 8120423, 8120424, 8120425, 8120426, 8120427, 8120428, 8120429, 8120430, 9010431, 9010432, 9010433, 9010434, 9010435, 9010436, 9010437, 9010438, 9010439, 9010440, 9010441, 9010442, 9010443, 9010444, 9010445, 9010446, 9010447, 9010448, 9010449, 9010450, 9020452, 9020453, 9020454, 9020455, 9020456, 9020457, 9020458, 9020459, 9020460, 9020461, 9020462, 9020463, 9020464, 9020465, 9020466, 9020467, 9020468, 9020469, 9020470, 90204

Risk classification

Class II

Area (FDA)

device

Country

Japan