Z-2621-2024 Class II Ongoing
FDA device recall Z-2621-2024 was initiated by DKK Dai-Ichi Shomei Co., Ltd. on July 9, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 538 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2024
- Initiation Date
- July 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 538 units
Product Description
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
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.
Distribution Pattern
Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
Code Information
Model Number: AUA7-LH/7TV-LH; UDI-DI: 10841736100025; Serial Numbers: 07120133, 2015-03-0001, 2015-03-0002, 2015-03-0003, 2015-03-0004, 2015-03-0005, 2015-03-0006, 2015-03-0007, 2015-03-0008, 2015-03-0009, 2015-03-0010, 2015-04-0011, 2015-04-0012, 2015-04-0013, 2015-04-0014, 2015-04-0015, 2015-04-0016, 2015-04-0017, 2015-04-0018, 2015-04-0019, 2015-04-0020, 2015-04-0021, 2015-04-0022, 2015-04-0023, 2015-04-0024, 2015-04-0025, 2015-05-0026, 2015-05-0027, 2015-05-0028, 2015-05-0029, 2015-05-0030, 2015-05-0031, 2015-05-0032, 2015-05-0033, 2015-05-0034, 2015-05-0035, 2015-05-0036, 2015-05-0037, 2015-05-0038, 2015-05-0039, 2015-05-0040, 2015-06-0041, 2015-06-0042, 2015-06-0043, 2015-06-0044, 2015-06-0045, 2015-06-0046, 2015-06-0047, 2015-06-0048, 2015-06-0049, 2015-06-0050, 2015-06-0051, 2015-06-0052, 2015-06-0053, 2015-06-0054, 2015-06-0055, 2015-07-0056, 2015-07-0057, 2015-07-0058, 2015-07-0059, 2015-07-0060, 2015-07-0061, 2015-07-0062, 2015-07-0063, 2015-07-0064, 2015-07-0065, 2015-07-0066, 2015-07-0067, 2015-07-0068, 2015-07-0069, 2015-07-0070, 2015-08-0071, 2015-08-0072, 2015-08-0073, 2015-08-0074, 2015-08-0075, 2015-08-0076, 2015-08-0077, 2015-08-0078, 2015-08-0079, 2015-08-0080, 2015-08-0081, 2015-08-0082, 2015-08-0083, 2015-08-0084, 2015-08-0085, 2015-08-0086, 2015-08-0087, 2015-08-0088, 2015-08-0089, 2015-08-0090, 2015-09-0091, 2015-09-0092, 2015-09-0093, 2015-09-0094, 2015-09-0095, 2015-09-0096, 2015-09-0097, 2015-09-0098, 2015-09-0099, 2015-09-0100, 2015-10-0101, 2015-10-0102, 2015-10-0103, 2015-10-0104, 2015-10-0105, 2015-10-0106, 2015-10-0107, 2015-10-0108, 2015-10-0109, 2015-10-0110, 2015-11-0111, 2015-11-0112, 2015-11-0113, 2015-11-0114, 2015-11-0115, 2015-11-0116, 2015-11-0117, 2015-11-0118, 2015-11-0119, 2015-11-0120, 2015-11-0121, 2015-11-0122, 2015-11-0123, 2015-11-0124, 2015-11-0125, 2015-11-0126, 2015-11-0127, 2015-11-0128, 2015-11-0129, 2015-11-0130, 2015-12-0131, 2015-12-0132, 2015-12-0133, 2015-12-0134, 2015-12-0135, 2015-12-0136, 2015-12-0137, 2015-12-0138, 2015-12-0139, 2015-12-0140, 2015-12-0141, 2015-12-0142, 2015-12-0143, 2015-12-0144, 2015-12-0145, 2016-01-0146, 2016-01-0147, 2016-01-0148, 2016-01-0149, 2016-01-0150, 2016-01-0151, 2016-01-0152, 2016-01-0153, 2016-01-0154, 2016-01-0155, 2016-01-0156, 2016-0156, 2016-02-0157, 2016-02-0158, 2016-02-0159, 2016-02-0160, 2016-02-0162, 2016-02-0163, 2016-04-0164, 2016-04-0165, 2016-04-0166, 2016-04-0167, 2016-04-0168, 2016-04-0169, 2016-04-0170, 2016-05-0171, 2016-05-0172, 2016-05-0173, 2016-05-0174, 2016-05-0175, 2016-05-0176, 2016-05-0177, 2016-05-0178, 2016-05-0179, 2016-05-0180, 2016-05-0181, 2016-05-0182, 2016-05-0183, 2016-05-0184, 2016-05-0185, 2016-06-0186, 2016-06-0187, 2016-06-0188, 2016-06-0189, 2016-06-0190, 2016-06-0191, 2016-06-0192, 2016-06-0193, 2016-06-0194, 2016-06-0195, 2016-06-0196, 2016-07-0197, 2016-07-0198, 2016-07-0199, 2016-07-0200, 2016-07-0201, 2016-07-0202, 2016-07-0203, 2016-09-0204, 2016-09-0205, 2016-09-0206, 2016-09-0207, 2016-09-0208, 2016-09-0209, 2016-09-0210, 2016-09-0211, 2016-09-0212, 2016-09-0213, 2016-09-0214, 2016-09-0215, 2016-09-0216, 2016-09-0217, 2016-09-0218, 2016-09-0219, 2016-09-0220, 2016-09-0221, 2016-09-0222, 2016-09-0223, 2016-10-0224, 2016-10-0225, 2016-11-0226, 2016-11-0227, 2016-11-0228, 2016-11-0229, 2016-12-0230, 2016-12-0231, 2016-12-0232, 2016-12-0233, 2016-12-0234, 2016-12-0235, 2016-12-0236, 2016-12-0237, 2016-12-0238, 2016-12-0239, 2016-12-0240, 2016-12-0241, 2016-12-0242, 2016-12-0243, 2017-01-0244, 2017-01-0245, 2017-01-0247, 2017-01-0248, 2017-01-0249, 2017-01-0250, 2017-01-0251, 2017-01-0252, 2017-01-0253, 2017-01-0254, 2017-01-0255, 2017-02-0256, 2017-02-0257, 2017-02-0258, 2017-02-0259, 2017-02-0260, 2017-03-0261, 2017-03-0262, 2017-03-0263, 2017-03-0264, 2017-03-0265, 2017-03-0266, 2017-03-0267, 2017-03-0268, 2017-03-0269, 2017-03-0270, 2017-03-0271, 2017-03-0272, 2017-03-0273, 2017-03-0274, 2017-03-0275, 2017-03-0276, 2017-03-0277, 2017-03-0278, 2017-03-0279, 2017-04-0280, 2017-04-0281, 2017-04-0282, 2017-04-0283, 2017-05-0285, 2017-05-0286, 2017-05-0287, 2017-05-0288, 2017-05-0289, 2017-05-0290, 2017-05-0291, 2017-05-0292, 2017-06-0293, 2017-06-0294, 2017-06-0295, 2017-06-0296, 2017-07-0297, 2017-07-0298, 2017-07-0299, 2017-07-0302, 2017-07-0303, 2017-07-0304, 2017-07-300, 2017-07-301, 2017-08-0305, 2017-08-0306, 2017-08-0307, 2017-08-0308, 2017-08-0309, 2017-08-0310, 2017-08-0311, 2017-08-0312, 2017-08-0313, 2017-08-0314, 2017-08-0315, 2017-08-0316, 2017-08-0317, 2017-09-0318, 2017-09-0319, 2017-09-0320, 2017-09-0321, 2017-09-0322, 2017-09-0323, 2017-09-0324, 2017-09-0325, 2017-09-0326, 2017-09-0327, 2017-09-0328, 2017-09-0329, 2017-09-0330, 2017-09-0331, 2017-09-0332, 2017-09-0333, 2017-09-0334, 2017-09-0335, 2017-09-0336, 2017-09-0337, 2017-09-0338, 2017-09-0339, 2017-09-0340, 2017-10-0341, 2017-10-0342, 2017-10-0343, 2017-10-0344, 2017-10-0345, 2017-10-0347, 2017-10-0348, 2017-10-0349, 2017-10-0350, 2017-10-0351, 2017-10-0352, 2017-10-0353, 2017-11-0354, 2017-11-0355, 2017-11-0356, 2017-11-0357, 2017-11-0358, 2017-11-0359, 2017-11-0360, 2017-11-0361, 2017-11-0362, 2017-12-0363, 2017-12-0364, 2017-12-0365, 2017-12-0366, 2018-01-0367, 2018-01-0368, 2018-01-0369, 2018-01-0370, 2018-01-0371, 2018-02-0372, 2018-02-0373, 2018-02-0374, 2018-02-0375, 2018-02-0376, 2018-02-0377, 2018-02-0378, 2018-02-0379, 2018-02-0380, 2018-03-0381, 2018-03-0382, 2018-03-0383, 2018-03-0384, 2018-03-0385, 2018-03-0386, 2018-03-0387, 2018-03-0388, 2018-03-0389, 2018-03-0390, 2018-04-0391, 2018-04-0392, 2018-04-0393, 2018-04-0394, 2018-04-0395, 2018-04-0396, 2018-04-0397, 2018-04-0398, 2018-04-0399, 2018-04-0400, 2018-05-0401, 2018-05-0402, 2018-05-0403, 2018-05-0404, 2018-05-0405, 2018-05-0406, 2018-05-0407, 2018-06-0408, 2018-06-0409, 2018-06-0410, 2018-06-0411, 2018-06-0412, 2018-06-0413, 2018-06-0414, 2018-07-0416, 2018-07-0417, 2018-07-0418, 2018-07-0419, 2018-07-0420, 2018-07-0421, 2018-08-0422, 2018-08-0423, 2018-11-0424, 2018-11-0425, 2018-12-0426, 2018-12-0427, 2019-01-0428, 2019-01-0429, 2019-02-0430, 2019-03-0431, 2019-03-0432, 2019-03-0433, 2019-03-0434, 2019-04-0435, 2019-04-0436, 2019-05-0437, 2019-05-0438, 2019-07-0439, 2019-07-0440, 2019-07-0441, 2019-07-0442, 2019-07-0443, 2019-07-0444, 2019-07-0445, 2019-07-0446, 2019-08-0447, 2020-01-0448, 2020-01-0449, 2020-03-0450, 2020-03-0451, 2020-06-0452, 2020-06-0453, 2020-07-0454, 2020-07-0455, 2020-09-0456, 2020-09-0457, 2020-10-0458, 2020-10-0459, 2020-10-0460, 2020-10-0461, 2020-11-0462, 2020-11-0463, 2020-11-0464, 2020-11-0465, 2020-11-0466, 2020-11-0467, 2020-11-0468, 2020-11-0469, 2020-12-0470, 2020-12-0471, 2021-06-0473, 2021-06-0474, 2021-07-0477, 2021-07-0478, 2021-10-0479, 2021-10-0480, 2021-11-0481, 2021-11-0482, 2021-11-0483, 2021-11-0484, 2021-12-0485, 2022-01-0486, 2022-01-0487, 2022-01-0488, 2022-01-0489, 2022-02-0490, 2022-03-0491, 2022-03-0492, 2022-04-0493, 2022-04-0494, 2022-04-0495, 2022-04-0496, 2022-04-0497, 2022-04-0498, 2022-04-0499, 2022-04-0500, 2022-04-0501, 2022-04-0502, 2022-04-0503, 2022-05-0504, 2022-06-0505, 2022-06-0506, 2022-07-0507, 2022-07-0508, 2022-09-0509, 2022-09-0510, 2022-09-0511, 2022-09-0512, 2022-09-0513, 2022-09-0514, 2022-09-0515, 2022-09-0516, 2022-09-0517, 2022-09-0518, 2022-09-0519, 2022-10-0521, 2022-10-0522, 2023-04-0533, 2023-04-0534, 2023-04-0535, 2023-04-0536, 2023-04-0537, 2023-04-0538, 2023-04-0539, 2023-04-0540, 2023-05-0541, 2023-05-0542, 2023-05-0543, 2023-07-0544, 2023-07-0545, 2023-07-0546, 2023-07-0547, 2023-07-0548, 2023-07-0549, 2023-07-0550, 2023-07-0551, 2023-07-0552, 2023-07-0553, 2023-11-0554, 2023-11-0555,