FDAFDA · Alimentos y medicamentos·N.º oficial Z-2618-2024
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.
Publicado el 21 de agosto de 2024 · Inicio del retiro: 9 de julio de 2024
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
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- DKK Dai-Ichi Shomei Co., Ltd.
- Distribuidor
- Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Japan
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