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FDA (Device enforcement)Recalled 2024-10-07class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Zenition 70, Model Number: 718133

Hazard

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

Details from the source

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

UPC codes

00884838091528

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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