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U.S. Department of Health and Human Services

Class 2 Device Recall Aurora 3 series

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 Class 2 Device Recall Aurora 3 seriessee related information
Date Initiated by FirmJuly 09, 2024
Date PostedAugust 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2620-2024
Recall Event ID 94979
510(K)NumberK071698 
Product Classification Light, surgical, ceiling mounted - Product Code FSY
ProductAurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Code Information Model Number: AUT7-LH/TV-LH; Serial Numbers: 13040011, 13040012, 13040013, 13040014, 13040015, 13040016, 13040017, 13040018, 13040019, 13040020, 13040021, 13040022, 13040023, 13040024, 13070025, 13070026, 13070027, 13070028, 13070029, 13070030, 13070031, 13070032, 13070033, 13070034, 13070035, 13070036, 13070037, 13070038, 13070039, 13070040, 13070041, 13070042, 13070043, 13080044, 13080045, 13080046, 13080047, 13080048, 13080049, 13080050, 13080051, 13080052, 13080053, 13090054, 13090055, 13090056, 13090057, 13090058, 13090059, 13090060, 13090061, 13090062, 13090063, 13090064, 13090065, 13090066, 13090067, 13090068, 13090069, 13090070, 13090071, 13090072, 13090073, 13090074, 13090075, 13090076, 13090077, 13100078, 13100079, 13100080, 13100081, 13100082, 13100083, 13100084, 13100085, 13100086, 13100087, 13100088, 13100089, 13100090, 13100091, 13100092, 13100093, 13100094, 13100095, 13100096, 13100097, 13110098, 13110099, 13110100, 13110101, 13110102, 13110103, 13110104, 13110105, 13110106, 13110107, 13110108, 13110109, 13110110, 13110111, 13120112, 13120113, 13120114, 14010115, 14010116, 14010117, 14010118, 14010119, 14010120, 14010121, 14010122, 14010123, 14010124, 14010125, 14010126, 14010127, 14010128, 14010129, 14010130, 14010131, 14010132, 14010133, 14020134, 14020135, 14020136, 14020137, 14020138, 14020139, 14020140, 14020141, 14020142, 14020143, 14020144, 14020145, 14020146, 14020147, 14020148, 14020149, 14020150, 14020151, 14020152, 14020153, 14030154, 14030155, 14030156, 14030157, 14030158, 14030159, 14030160, 14030161, 14030162, 14030163, 14030164, 14030165, 14030166, 14030167, 14030168, 14030169, 14030170, 14030171, 14030172, 14030173, 14040174, 14040175, 14040176, 14040177, 14040178, 14040179, 14040180, 14040181, 14040182, 14040183, 14040184, 14040185, 14040186, 14040187, 14040188, 14040189, 14040190, 14040191, 14040192, 14040193, 14040194, 14040195, 14040196, 14040197, 14040198, 14040199, 14040200, 14040201, 14040202, 14040203, 14040204, 14040205, 14040206, 14040207, 14040208, 14040209, 14040210, 14040211, 14040212, 14040213, 14050214, 14050215, 14050216, 14050217, 14050218, 14050219, 14050220, 14050221, 14050222, 14050223, 14050224, 14050225, 14050226, 14050227, 14050228, 14050229, 14050230, 14050231, 14050232, 14050233, 14050234, 14050235, 14050236, 14050237, 14050238, 14050239, 14050240, 14050241, 14050242, 14050243, 14050244, 14050245, 14050246, 14050247, 14050248, 14050249, 14050250, 14050251, 14050252, 14050253, 14060254, 14060255, 14060256, 14060257, 14060258, 14070259, 14070260, 14070261, 14070262, 14070263, 14070264, 14070265, 14070266, 14070267, 14070268, 14070269, 14070270, 14070271, 14070272, 14070273, 14070274, 14070275, 14070276, 14070277, 14070278, 14070279, 14070280, 14070281, 14070282, 14070283, 14070284, 14070285, 14070286, 14070287, 14070288, 14080289, 14080290, 14080291, 14080292, 14080293, 14080294, 14080295, 14080296, 14080297, 14080298, 14080299, 14080300, 14080301, 14080302, 14080303.
Recalling Firm/
Manufacturer		 DKK Dai-Ichi Shomei Co., Ltd.
1 Chome 32-26
Sakashita
Itabashi Japan
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn July 9, 2024 URGENT: Aurora 7 Lighthead Series RECALL letters were sent to customers. Actions to be taken by the customer: Contact the end users and tell them to discontinue the use of the product. Please send an acknowledgement letter or email to Dai-ichi Shomei to let us know that you have received this Field Action Advisory Notice within 3 days after you receive the Notice. Actions to be Taken by the Manufacturer: The physical correction will be announced later. Contact information for questions: email info@hospilite.co.jp
Quantity in Commerce293 units
DistributionDomestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FSY
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