Z-2620-2024 Class II Ongoing

Recalled by DKK Dai-Ichi Shomei Co., Ltd. — Itabashi

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
293 units

Product Description

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.

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: 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,