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.

Recall details

Manufacturer

DKK Dai-Ichi Shomei Co., Ltd.

Distributor

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

Lot

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, 201

Risk classification

Class II

Area (FDA)

device

Country

Japan