Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is in...
FDA Device Recall #Z-2621-2024 — Class II — July 9, 2024
Recall Summary
| Recall Number | Z-2621-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 9, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DKK Dai-Ichi Shomei Co., Ltd. |
| Location | Itabashi |
| Product Type | Devices |
| 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.
Lot / 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, 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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, 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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,
Other Recalls from DKK Dai-Ichi Shomei Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2618-2024 | Class II | Aurora Series, Aurora 7 lighthead; Models: LED7... | Jul 9, 2024 |
| Z-2620-2024 | Class II | Aurora 3 Series, Aurora 7 lighthead; Models: AU... | Jul 9, 2024 |
| Z-2619-2024 | Class II | Aurora 2 Series, Aurora 7 lighthead; Models: AU... | Jul 9, 2024 |
| Z-0072-2024 | Class II | LFS Flat screen support arm systems without sur... | Aug 23, 2023 |
| Z-0071-2024 | Class II | LFS Flat screen arm system with surgical lamp f... | Aug 23, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.