Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
Reason for recall: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary Quantity: 2,247 units (582 US, 84 Canada, 1,581 R.O.W.) Lot/code info: Model Number: 718133; UDI-DI: (01)00884838091528(21); Serial Numbers: 420, 4093, 2851, 3947, 2571, 4211, 3325, 3326, 2324, 3665, 491, 480, 579, 580, 581, 582, 4138, 71, 3657, 3660, 3889, 669, 670, 671, 233, 3416, 4351, 4352, 4353, 4355, 3971, 3972, 4387, 4278, 2880, 3366, 4062, 4063, 3374, 4201, 4083, 1290, 3894, 932, 933, 4309, 1796, 3355, 3680, 4156, 562, 1983, 4206, 3395, 1310, 3758, 63, 1787, 2888, 684, 235, 557, 4014, 2056, 3658, 3661, 1801, 108, 109, 3354, 572, 1901, 4431, 1086, 1868, 1899, 1758, 2081, 4223, 626, 652, 654, 655, 829, 1786, 2957, 3800, 1904, 3393, 4155, 4302, 3523, 4170, 4432, 651, 85, 4013, 3973, 1902, 563, 2202, 1903, 4386, 234, 2720, 202, 553, 3686, 822, 672, 3631, 72, 3892, 3893, 3895, 3896, 4176, 3491, 2958, 1219, 3392, 653, 1195, 1900, 4147, 2938, 1072, 101, 103, 2106, 1569, 3394, 1848, 1852, 4020, 4186, 3604, 106, 4096, 561, 1802, 4094, 3348, 1837, 944, 1192, 1625, 1194, 4396, 4279, 4280, 3683, 1944, 3940, 2887, 1204, 62, 1536, 1212, 20, 52, 1675, 2380, 2381, 2681, 2276, 2342, 1525, 1224, 2105, 3385, 3459, 1581, 2680, 4111, 2172, 3583, 1599, 1945, 4252, 1451, 4167, 4171, 3133, 3135, 3585, 3933, 3623, 1619, 1621, 29, 3582, 2549, 3048, 2203, 3560, 2721, 435, 474, 49, 3741, 1422, 1423, 1, 10, 11, 12, 13, 2, 3, 4, 5, 6, 7, 8, 9, 1143, 2715, 2804, 1839, 3118, 1196, 50, 4570, 2705, 32, 1376, 1377, 1379, 1381, 2747, 65, 3313, 66, 68, 69, 70, 512, 796, 1919, 2639, 2155, 2156, 1922, 1095, 1096, 2323, 3496, 3497, 3870, 1288, 2570, 311, 3387, 3682, 4035, 4036
00884838091528
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.