DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan Aurora 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aurora 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.
Brand
DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan
Lot Codes / Batch Numbers
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.
Products Sold
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.
DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan is recalling Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intend due to 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,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026