CLASS II ONGOING Device recall · Reported 21 Aug 2024 · FDA Enforcement Report

Aurora Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co

DKK Dai-Ichi Shomei Co is recalling Aurora Series, Aurora 7 lighthead, distributed nationwide in the US. The recall was initiated on 9 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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, 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9020468, 9020469, 9020470, 9020471, 9020472, 9020473, 9020474, 9020475, 9020476, 9020477, 9030478, 9030479, 9030480, 9030481, 9030482, 9030483, 9030484, 9030486, 9030487, 9030488, 9030489, 9030490, 9030491, 9030492, 9030493, 9030494, 9030495, 9030496, 9030497, 9030498, 9030499, 9030500, 9030501, 9030502, 9030503, 9030504, 9030505, 9040506, 9040507, 9060509, 9060510, 9060511, 9060512, 9060513, 9060514, 9060515, 9060516, 9070517, 9070518, 9070519, 9070520, 9070521, 9080531, 9080532, 9080533, 9080534, 9080535, 9080536, 9080537, 9080538, 9080539, 9080540, 9080541, 9120543, 9120544, 10010545, 10010546, 10010547, 10010548, 10010549, 10020055, 10020551, 10020552, 10020553, 10020554, 10020555, 10020556, 10020557, 10030558, 10030559, 10030560, 10030561, 10030562, 10030563, 10030564, 10030565, 10030566, 10030567, 10040568, 10040569, 10040570, 10040571, 10040572, 10040573, 10050574, 10050575, 10050576, 10050577, 10050578, 10050579, 10080580, 10080581, 10080582, 10080583, 10080584, 10090585, 10090586, 10090587, 10090588, 10090589, 10090590, 10090591, 12070597, 12070598, 12080599, 12080600, 12080601, 12080602, 12080603, 12080604,
Quantity recalled555 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2618-2024
FDA event ID
94979
Recalling firm
DKK Dai-Ichi Shomei Co, Itabashi
Classification
Class II
Status
Ongoing
Recall initiated
9 Jul 2024
FDA classified
14 Aug 2024
Reported
21 Aug 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material

Timeline

9 Jul 2024Recall initiated by company
14 Aug 2024Classified by FDA+36 days
21 Aug 2024Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is Aurora Series, Aurora 7 lighthead recalled?

Yes. DKK Dai-Ichi Shomei Co recalled Aurora Series, Aurora 7 lighthead on 9 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-2618-2024.

Why was it recalled?

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.

Which lots are affected?

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, 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10090588, 10090589, 10090590, 10090591, 12070597, 12070598, 12080599, 12080600, 12080601, 12080602, 12080603, 12080604,

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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