EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C,…

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• EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option
• Model
  • EPIQ 5G
  • EPIC 5C
  • EPIQ 5W
• Catalog Number795204 / 795205
• Part Number989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis

Lot codes and dates

• ********************SYSTEM BASE ID IN THE US***************************** US114C0207, US114C0208, US114C0209, US114C0287, US114C0308, US114C0323, US114C0330, US114C0445, US114C0713, US114C0714, US114C0731, US115C0139, US115C0464, US115C0465, US115C0470, US115C0471, US115C0537, US115C0538, US115C0539, US115C0576, US115C0607, US214C0042, US214C0084, US214C0103, US214C0104, US214C0105, US214C0141, US214C0142, US214C0162, US214C0180, US214C0434, US215C0068, US215C0069, US215C0070, US215C0072, US215C0073, US215C0074, US215C0171, US215C0172, US215C0178, US215C0179, US215C0180, US215C0306, US215C0307, US215C0308, US215C0406, US215C0407, US215C0449, US215C0450, US215C0512, US215C0513, US215C0514, US215C0516, US215C0534, US215C0535, US215C0538, US215C0539, US215C0571, US215C0572, US215C0573, US215C0615, US215C0616, US215C0617, US215C0618, US215C0619, US215C0620, US215C0624, US215C0625, US215C0626, US215C0627, US215C0713, US215C0714, US215C0715, US215C0716, US215C0717, US215C0769, US215C0770, US215C0771, US215C0772, US215C0773, US215C0845, US215C1047, US215C1048, US314C0105, US314C0237, US314C0323, US314C0324, US314C0325, US314C0445, US314C0447, US315C0100, US315C0101, US315C0217, US315C0407, US315C0408, US315C0409, US315C0410, US315C0412, US315C0413, US315C0414, US315C0416, US315C0417, US413C0106, US413C0166, US413C0167, US413C0188, US413C0189, US413C0190, US413C0193, US413C0306, US413C0307, US413C0308, US413C0309, US413C0456, US413C0458, US414C0209, US414C0232, US414C0233, US414C0479, US414C0533, US414C0535, US513C0066, US513C0103, US513C0104, US513C0383, US513C0384, US513C0389, US513C0390, US513C0586, US513C0588, US514C0082, US514C0083, US514C0104, US514C0105, US514C0106, US514C0117, US514C0240, US514C0301, US514C0561, US514C0563, US514C0564, US514C0565, US514C0566, US514C0593, US514C0594, US514C0595, US514C0596, US514C0597, US514C0672, US514C0735, US514C0736, US514C0737, US613C0035, US613C0050, US613C0058, US613C0059, US613C0060, US613C0061, US613C0246, US613C0247, US613C0248, US613C0249, US614C0026, US614C0027, US614C0028, US614C0072, US614C0243, US614C0244, US614C0273, US614C0274, US614C0275, US614C0276, US614C0277, US614C0278, US614C0290, US614C0291, US614C0292, US614C0293, US614C0332, US614C0442, US614C0465, US614C0499, US614C0505, US614C0682, US614C0699, US614C0732, US614C0743, US614C0846, US614C0847, US614C0848, US614C0849, US614C0850, US614C0851, US614C0852, US614C0853, US614C0869, US614C0870, US614C0871, US614C0915, US614C0916, US614C0917, US714C0074, US714C0075, US714C0099, US714C0123, US714C0125, US714C0127, US714C0129, US714C0130, US714C0161, US714C0162, US714C0163, US714C0200, US714C0249, US714C0250, US714C0252, US714C0253, US714C0269, US714C0287, US714C0288, US714C0303, US714C0328, US714C0329, US714C0404, US714C0405, US714C0417, US714C0465, US714C0527, US714C0528, US714C0581, US814C0075, US814C0138, US814C0154, US814C0175, US814C0176, US814C0228, US814C0234, US814C0282, US814C0283, US814C0284, US814C0285, US814C0286, US814C0299, US814C0300, US814C0365, US814C0405, US814C0406, US814C0407, US814C0535, US814C0582, US814C0583, US814C0584, US814C0603, US814C0628, US913C0348, US914C0020, US914C0021, US914C0054, US914C0075, US914C0134, US914C0181, US914C0182, US914C0191, US914C0202, US914C0203, US914C0204, US914C0243, US914C0262, US914C0418, US914C0419, US914C0486, US914C0619, US914C0620, US914C0621, US914C0622, US914C0623, US914C0739, US914C0740, US914C0741, US914C0875, US914C0911, US914C0912, US914C0913, US914C0914, US914C0996, USD13C0236, USD13C0500, USD13C0501, USD13C0502, USD13C0568, USD13C0572, USD13C0573, USD13C0622, USD13C0623, USD13C0643, USD13C0644, USD13C0669, USD13C0709, USD13C0726, USD14B1047, USD14C0115, USD14C0165, USD14C0166, USD14C0402, USD14C0403, USD14C0404, USD14C0405, USD14C0406, USD14C0407, USD14C0408, USD14C0522, USD14C0523, USD14C0524, USD14C0525, USD14C0526, USD14C0598, USD14C0599, USD14C0600, USD14C0601, USD14C0602, USD14C0606, USD14C0660, USD14C0754, USD14C0755, USD14C0756, USD14C0757, USD14C0762, USD14C0763, USD14C0764, USD14C0765, USD14C0877, USD14C0878, USD14C0879, USD14C0880, USD14C0881, USD14C0882, USD14C0883, USD14C0884, USD14C0885, USD14C0965, USD14C0966, USD14C0967, USD14C0968, USD14C0969, USD14C0970, USD14C0971, USD14C1019, USD14C1020, USD14C1021, USD14C1022, USD14C1023, USD14C1041, USD14C1042, USD14C1043, USN13C0341, USN13C0342, USN13C0394, USN13C0395, USN13C0396, USN13C0458, USN13C0463, USN13C0576, USN13C0577, USN13C0578, USN14C0032, USN14C0033, USN14C0034, USN14C0035, USN14C0036, USN14C0039, USN14C0103, USN14C0185, USN14C0186, USN14C0240, USN14C0366, USN14C0367, USN14C0380, USN14C0408, USN14C0418, USN14C0442, USN14C0464, USN14C0467, USN14C0468, USN14C0471, USN14C0472, USN14C0535, USN14C0536, USN14C0696, USN14C0697, USN14C0779, USN14C0886, USN14C0887, USN14C0943, USN14C0944, USN14C0945, USO13C0118, USO13C0119, USO13C0120, USO13C0346, USO13C0347, USO13C0348, USO13C0349, USO13C0351, USO13C0355, USO13C0356, USO13C0357, USO13C0380, USO13C0419, USO13C0458, USO13C0474, USO13C0475, USO13C0476, USO13C0477, USO13C0478, USO13C0479, USO13C0480, USO13C0481, USO13C0484, USO13C0485, USO13C0513, USO13C0514, USO13C0515, USO13C0516, USO13C0526, USO13C0527, USO13C0528, USO13C0529, USO13C0530, USO13C0531, USO13C0532, USO13C0533, USO13C0534, USO13C0535, USO13C0536, USO13C0537, USO13C0538, USO13C0539, USO13C0552, USO13C0575, USO13C0576, USO13C0577, USO13C0578, USO13C0579, USO13C0580, USO13C0581, USO13C0582, USO13C0583, USO13C0584, USO13C0585, USO13C0586, USO13C0587, USO13C0588, USO13C0613, USO14C0034, USO14C0054, USO14C0055, USO14C0081, USO14C0095, USO14C0097, USO14C0166, USO14C0278, USO14C0279, USO14C0280, USO14C0281, USO14C0282, USO14C0340, USO14C0377, USO14C0378, USO14C0380, USO14C0480, USO14C0481, USO14C0517, USO14C0570, USO14C0609, USO14C0610, USO14C0660, USO14C0662, USO14C0663, USO14C0664, USO14C0665, USO14C0666, USO14C0805, USO14C0806, USO14C0807, USO14C0808, USO14C0846, USO14C1090, USO14C1092, USO14C1117, and USO14C1118. *********************SYSTEM BASE ID IN CANANA**************************** US115C0433, US115C0495, US115C0496, US115C0497, US115C0498, US115C0499, US115C0571, US215C0348, US215C0566, US215C0567, US215C0679, US215C1042, US315C0090, US315C0404, US315C0405, US315C0406, US414C0604, US714C0076, US714C0297, US814C0111, US914C0200, USD14C0156, USN14C0382, USN14C0383, USN14C0384, USO14C0511, USO14C0512, and USO14C0566. ********************SYSTEM BASE ID IN OTHER COUNTRIES****************** US114B0005, US114B0006, US114C0081, US114C0082, US114C0107, US114C0110, US114C0143, US114C0144, US114C0145, US114C0146, US114C0147, US114C0148, US114C0192, US114C0193, US114C0194, US114C0211, US114C0238, US114C0309, US114C0320, US114C0348, US114C0363, US114C0366, US114C0408, US114C0409, US114C0442, US114C0446, US114C0532, US115C0017, US115C0052, US115C0053, US115C0054, US115C0100, US115C0101, US115C0137, US115C0138, US115C0141, US115C0178, US115C0179, US115C0180, US115C0181, US115C0212, US115C0213, US115C0214, US115C0216, US115C0276, US115C0277, US115C0278, US115C0430, US115C0431, US115C0432, US115C0447, US115C0448, US115C0469, US115C0500, US115C0501, US115C0502, US115C0503, US115C0532, US115C0533, US115C0534, US115C0535, US115C0536, US115C0565, US115C0567, US115C0568, US115C0569, US115C0570, US115C0572, US115C0575, US115C0605, US115C0606, US115C0617, US115C0645, US115C0646, US214C0018, US214C0019, US214C0020, US214C0023, US214C0043, US214C0202, US214C0203, US214C0426, US214C0480, US214C0483, US214C0581, US215C0027, US215C0028, US215C0029, US215C0030, US215C0032, US215C0033, US215C0035, US215C0067, US215C0129, US215C0173, US215C0176, US215C0303, US215C0304, US215C0305, US215C0346, US215C0364, US215C0365, US215C0380, US215C0381, US215C0515, US215C0532, US215C0533, US215C0537, US215C0568, US215C0579, US215C0580, US215C0614, US215C0678, US215C0718, US215C0763, US215C0915, US215C0916, US215C0919, US215C0920, US215C0921, US215C0926, US215C0927, US215C0949, US215C1008, US215C1009, US215C1011, US215C1043, US215C1046, US314C0155, US314C0168, US314C0169, US314C0170, US314C0236, US314C0358, US314C0443, US315C0051, US315C0052, US315C0053, US315C0085, US315C0086, US315C0087, US315C0088, US315C0089, US315C0091, US315C0092, US315C0093, US315C0094, US315C0095, US315C0096, US315C0099, US315C0198, US315C0199, US315C0200, US315C0201, US315C0203, US315C0204, US315C0205, US315C0206, US315C0207, US315C0213, US315C0214, US315C0216, US315C0219, US315C0220, US315C0221, US315C0222, US315C0223, US315C0411, US414C0034, US414C0036, US414C0065, US414C0070, US414C0230, US414C0514, US414C0615, US414C0642, US414C0643, US414C0644, US414C0645, US414C0646, US414C0653, US513C0411, US514C0107, US514C0118, US514C0238, US514C0239, US514C0276, US514C0277, US514C0298, US514C0300, US514C0302, US514C0372, US514C0496, US514C0497, US514C0498, US514C0499, US514C0500, US514C0501, US514C0502, US514C0533, US514C0534, US514C0559, US514C0562, US514C0656, US514C0665, US514C0666, US514C0667, US514C0683, US514C0685, US514C0729, US514C0730, US514C0731, US514C0733, US514C0734, US514C0738, US514C0739, US514C0740, US614C0023, US614C0025, US614C0071, US614C0153, US614C0158, US614C0190, US614C0191, US614C0193, US614C0231, US614C0242, US614C0279, US614C0331, US614C0334, US614C0420, US614C0439, US614C0440, US614C0479, US614C0480, US614C0668, US614C0689, US614C0690, US614C0780, US614C0781, US614C0844, US614C0845, US714C0072, US714C0073, US714C0122, US714C0124, US714C0128, US714C0165, US714C0166, US714C0171, US714C0217, US714C0218, US714C0251, US714C0270, US714C0289, US714C0290, US714C0323, US714C0324, US714C0368, US714C0369, US714C0462, US714C0507, US714C0509, US714C0510, US714C0511, US714C0530, US714C0531, US714C0532, US714C0568, US714C0580, US714C0582, US714C0664, US714C0670, US714C0697, US714C0698, US714C0699, US714C0737, US814C0011, US814C0012, US814C0013, US814C0026, US814C0027, US814C0028, US814C0074, US814C0112, US814C0113, US814C0114, US814C0115, US814C0116, US814C0156, US814C0173, US814C0174, US814C0227, US814C0229, US814C0243, US814C0264, US814C0265, US814C0266, US814C0267, US814C0309, US814C0310, US814C0453, US814C0454, US814C0455, US814C0456, US814C0457, US814C0459, US814C0460, US814C0463, US814C0464, US814C0465, US814C0466, US814C0467, US814C0470, US814C0471, US814C0505, US814C0506, US814C0507, US814C0509, US814C0511, US814C0533, US814C0534, US814C0536, US814C0564, US814C0565, US814C0566, US814C0567, US814C0568, US814C0569, US814C0570, US814C0571, US814C0572, US814C0601, US814C0602, US914C0015, US914C0016, US914C0024, US914C0036, US914C0050, US914C0051, US914C0052, US914C0199, US914C0201, US914C0205, US914C0244, US914C0269, US914C0307, US914C0308, US914C0309, US914C0310, US914C0311, US914C0312, US914C0322, US914C0323, US914C0324, US914C0359, US914C0374, US914C0375, US914C0484, US914C0616, US914C0632, US914C0633, US914C0634, US914C0635, US914C0738, US914C0743, US914C0871, US914C0872, US914C0908, US914C0909, US914C0910, US914C0915, US914C0956, US914C0959, US914C0960, USD13C0032, USD13C0037, USD13C0069, USD13C0074, USD13C0232, USD13C0238, USD13C0259, USD13C0260, USD13C0261, USD13C0262, USD13C0289, USD13C0290, USD13C0364, USD13C0444, USD13C0727, USD13C0728, USD13C0730, USD13C0731, USD13C0732, USD13C0733, USD13C0734, USD13C0786, USD13C0787, USD14C0040, USD14C0041, USD14C0042, USD14C0043, USD14C0044, USD14C0045, USD14C0046, USD14C0112, USD14C0113, USD14C0155, USD14C0157, USD14C0158, USD14C0159, USD14C0160, USD14C0161, USD14C0162, USD14C0163, USD14C0164, USD14C0280, USD14C0282, USD14C0283, USD14C0286, USD14C0287, USD14C0364, USD14C0365, USD14C0366, USD14C0367, USD14C0399, USD14C0401, USD14C0409, USD14C0475, USD14C0489, USD14C0517, USD14C0518, USD14C0519, USD14C0520, USD14C0521, USD14C0659, USD14C0665, USD14C0666, USD14C0667, USD14C0668, USN13C0245, USN13C0309, USN13C0310, USN13C0311, USN13C0312, USN13C0313, USN13C0378, USN13C0459, USN13C0462, USN13C0470, USN13C0498, USN13C0500, USN13C0503, USN13C0505, USN13C0531, USN13C0594, USN13C0659, USN14C0031, USN14C0037, USN14C0100, USN14C0143, USN14C0144, USN14C0187, USN14C0188, USN14C0238, USN14C0239, USN14C0310, USN14C0312, USN14C0363, USN14C0364, USN14C0368, USN14C0379, USN14C0381, USN14C0425, USN14C0426, USN14C0465, USN14C0466, USN14C0596, USN14C0597, USN14C0598, USN14C0599, USN14C0600, USN14C0616, USN14C0617, USN14C0623, USN14C0656, USN14C0657, USN14C0693, USN14C0694, USN14C0695, USN14C0730, USN14C0792, USN14C0793, USN14C0794, USN14C0884, USN14C0885, USN14C0888, USN14C0889, USN14C0890, USN14C0891, USN14C0939, USN14C0942, USN14C0946, USN14C1043, USN14C1045, USO13C0359, USO13C0360, USO13C0362, USO13C0363, USO13C0364, USO13C0365, USO13C0366, USO13C0367, USO13C0368, USO13C0369, USO13C0387, USO13C0395, USO13C0398, USO13C0404, USO13C0405, USO13C0406, USO13C0407, USO13C0455, USO13C0456, USO13C0464, USO13C0466, USO13C0467, USO13C0468, USO13C0469, USO13C0482, USO13C0483, USO13C0594, USO13C0596, USO13C0611, USO13C0612, USO13C0614, USO13C0615, USO13C0630, USO13C0679, USO13C0684, USO13C0686, USO14C0029, USO14C0030, USO14C0031, USO14C0032, USO14C0033, USO14C0035, USO14C0036, USO14C0037, USO14C0038, USO14C0039, USO14C0040, USO14C0093, USO14C0094, USO14C0123, USO14C0124, USO14C0277, USO14C0339, USO14C0376, USO14C0438, USO14C0439, USO14C0476, USO14C0477, USO14C0479, USO14C0514, USO14C0515, USO14C0516, USO14C0565, USO14C0567, USO14C0568, USO14C0569, USO14C0607, USO14C0608, USO14C0611, USO14C0612, USO14C0659, USO14C0667, USO14C0718, USO14C0719, USO14C0720, USO14C0763, USO14C0803, USO14C0804, USO14C0844, USO14C0923, USO14C0924, USO14C1115, USO14C1116, USO14C1181, and USO14C1182.

Amount recalled

Total 1108 units (490 units in US and 618 units outside the US)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

• EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology…

Why it was recalled

When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients Body Surface Area (BSA).

This product could cause temporary or reversible health problems — stop using it.