EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 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)
Enforcement
- Recall Number
- Z-1578-2015
- Event ID
- 71084
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Ultrasound, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 13, 2015
- Initiation Date
- April 10, 2015
- Classification Date
- May 5, 2015
- Termination Date
- February 29, 2016
- Address
- 22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States
Description
EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 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)
When Epiq 5 Ultrasound System, WITH 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 calculation of the patients Body Surface Area (BSA).
*********************SYSTEM CODES IN THE US*********************************** US114C0108, US114C0206, US114C0210, US114C0239, US114C0240, US114C0241, US114C0271, US114C0272, US114C0273, US114C0286, US114C0321, US114C0322, US114C0331, US114C0332, US114C0333, US114C0334, US114C0444, US114C0534, US114C0605, US114C0674, US115C0140, US115C0382, US115C0468, US214C0106, US214C0143, US214C0144, US214C0192, US214C0534, US214C0535, US214C0536, US215C0071, US215C0394, US215C0536, US215C0774, US215C0839, US215C0843, US215C0844, US215C1010, US215C1049, US215C1050, US314C0055, US314C0073, US314C0235, US314C0296, US314C0297, US314C0322, US314C0444, US314C0446, US314C0557, US314C0613, US314C0746, US314C0835, US315C0055, US414C0014, US414C0035, US414C0069, US414C0158, US414C0376, US414C0377, US414C0616, US514C0044, US514C0045, US514C0046, US514C0084, US514C0085, US514C0149, US514C0175, US514C0338, US514C0373, US514C0374, US514C0375, US514C0473, US514C0474, US514C0639, US514C0657, US514C0668, US514C0669, US514C0670, US514C0671, US514C0684, US514C0741, US514C0742, US614C0154, US614C0155, US614C0156, US614C0157, US614C0288, US614C0289, US614C0294, US614C0333, US614C0419, US614C0463, US614C0464, US614C0466, US614C0467, US614C0468, US614C0487, US614C0488, US614C0489, US614C0490, US614C0491, US614C0493, US614C0494, US614C0495, US614C0496, US614C0500, US614C0501, US614C0502, US614C0503, US614C0506, US614C0624, US614C0628, US614C0700, US714C0097, US714C0164, US714C0370, US714C0508, US814C0025, US814C0137, US814C0155, US814C0157, US914C0076, US914C0190, US914C0245, US914C0246, US914C0263, US914C0264, US914C0265, US914C0266, US914C0267, US914C0268, US914C0793, US914C0998, USD13B0662, USD13C0018, USD13C0070, USD13C0071, USD13C0072, USD13C0073, USD13C0234, USD13C0235, USD13C0237, USD13C0255, USD13C0256, USD13C0258, USD13C0291, USD13C0365, USD13C0439, USD13C0440, USD13C0441, USD13C0442, USD13C0443, USD13C0522, USD13C0523, USD13C0524, USD13C0525, USD13C0526, USD13C0527, USD13C0569, USD13C0570, USD13C0571, USD13C0583, USD13C0584, USD13C0585, USD13C0614, USD13C0615, USD13C0616, USD13C0617, USD13C0618, USD13C0619, USD13C0620, USD13C0621, USD13C0642, USD13C0668, USD13C0670, USD13C0671, USD13C0672, USD13C0678, USD13C0698, USD13C0707, USD13C0708, USD13C0710, USD13C0711, USD13C0712, USD13C0718, USD13C0719, USD13C0720, USD14C0167, USD14C0168, USD14C0370, USD14C0371, USD14C0372, USD14C0373, USD14C0374, USD14C0597, USD14C0603, USD14C0604, USD14C0605, USD14C0758, USD14C0759, USD14C0760, USD14C0886, USD14C0887, USD14C0888, USD14C0889, USD14C1024, USD14C1025, USN13B0039, USN13C0054, USN13C0182, USN13C0183, USN13C0184, USN13C0185, USN13C0281, USN13C0282, USN13C0283, USN13C0284, USN13C0285, USN13C0286, USN13C0362, USN13C0363, USN13C0379, USN13C0380, USN13C0504, USN13C0574, USN13C0575, USN13C0626, USN14C0038, USN14C0189, USN14C0298, USN14C0402, USN14C0780, USN14C1044, USO13C0350, USO13C0352, USO13C0353, USO13C0354, USO14C0056, USO14C0126, USO14C0127, USO14C0156, USO14C0157, USO14C0158, USO14C0159, USO14C0160, and USO14C0188. *****************************SYSTEM CODES IN CANADA******************** US115C0274, US115C0466, US115C0467, US115C0494, US214C0486, US215C0034, US215C0036, US215C0347, US414C0111, US414C0112, US414C0113, US414C0114, US414C0477, US414C0478, US514C0339, US614C0688, US614C0854, US914C0179, US914C0180, USN14C0237, and USO14C1093. ****************************SYSTEM CODES IN OTHER COUNTRIES************* US114C0077, US114C0078, US114C0079, US114C0080, US114C0105, US114C0106, US114C0109, US114C0190, US114C0191, US114C0284, US114C0285, US114C0361, US114C0362, US114C0365, US114C0378, US114C0405, US114C0406, US114C0407, US114C0443, US114C0505, US114C0531, US114C0533, US114C0672, US114C0673, US114C0675, US114C0730, US114C0751, US115C0018, US115C0055, US115C0097, US115C0098, US115C0099, US115C0215, US115C0275, US115C0383, US115C0449, US115C0450, US115C0463, US115C0564, US115C0566, US115C0573, US115C0574, US115C0616, US115C0647, US115C0648, US115C0649, US115C0650, US214C0017, US214C0021, US214C0022, US214C0044, US214C0045, US214C0085, US214C0086, US214C0087, US214C0140, US214C0177, US214C0178, US214C0179, US214C0250, US214C0416, US214C0417, US214C0418, US214C0419, US214C0420, US214C0421, US214C0422, US214C0423, US214C0424, US214C0425, US214C0477, US214C0478, US214C0479, US214C0481, US214C0482, US214C0484, US214C0485, US215C0031, US215C0130, US215C0131, US215C0174, US215C0175, US215C0177, US215C0344, US215C0345, US215C0382, US215C0383, US215C0384, US215C0429, US215C0430, US215C0431, US215C0432, US215C0433, US215C0434, US215C0468, US215C0511, US215C0529, US215C0530, US215C0531, US215C0569, US215C0570, US215C0574, US215C0575, US215C0576, US215C0577, US215C0578, US215C0621, US215C0622, US215C0623, US215C0764, US215C0765, US215C0766, US215C0840, US215C0841, US215C0842, US215C0912, US215C0913, US215C0914, US215C0917, US215C0918, US215C0922, US215C0923, US215C0924, US215C0925, US215C0950, US215C1044, US215C1045, US314C0054, US314C0067, US314C0068, US314C0069, US314C0070, US314C0071, US314C0072, US314C0100, US314C0101, US314C0102, US314C0103, US314C0104, US314C0167, US314C0199, US314C0200, US314C0201, US314C0230, US314C0231, US314C0232, US314C0233, US314C0234, US314C0298, US314C0299, US314C0300, US314C0321, US314C0728, US314C0729, US314C0730, US314C0742, US314C0743, US314C0744, US314C0745, US314C0775, US314C0776, US314C0777, US314C0778, US314C0779, US314C0798, US314C0799, US314C0800, US314C0801, US314C0834, US315C0049, US315C0054, US414C0012, US414C0013, US414C0037, US414C0038, US414C0066, US414C0067, US414C0068, US414C0074, US414C0075, US414C0076, US414C0077, US414C0078, US414C0109, US414C0110, US414C0142, US414C0157, US414C0159, US414C0231, US414C0307, US414C0384, US414C0395, US414C0519, US414C0614, US414C0647, US513C0412, US513C0539, US514C0024, US514C0081, US514C0108, US514C0115, US514C0116, US514C0272, US514C0273, US514C0274, US514C0275, US514C0299, US514C0472, US514C0535, US514C0536, US514C0537, US514C0538, US514C0539, US514C0540, US514C0541, US514C0542, US514C0543, US514C0544, US514C0545, US514C0546, US514C0560, US514C0636, US514C0637, US514C0638, US514C0718, US514C0732, US614C0024, US614C0189, US614C0192, US614C0383, US614C0418, US614C0441, US614C0497, US614C0498, US614C0745, US714C0071, US714C0077, US714C0078, US714C0079, US714C0080, US714C0081, US714C0095, US714C0096, US714C0121, US714C0135, US714C0167, US714C0170, US714C0199, US714C0254, US714C0255, US714C0291, US714C0304, US714C0439, US714C0461, US714C0464, US714C0505, US714C0506, US714C0548, US714C0736, US814C0023, US814C0024, US814C0244, US814C0311, US814C0423, US814C0424, US814C0425, US814C0426, US814C0427, US814C0428, US814C0429, US814C0430, US814C0458, US814C0461, US814C0462, US814C0468, US814C0469, US814C0508, US814C0510, US814C0626, US814C0627, US914C0017, US914C0018, US914C0019, US914C0053, US914C0261, US914C0376, US914C0377, US914C0378, US914C0483, US914C0485, US914C0636, US914C0701, US914C0737, US914C0742, US914C0873, US914C0874, US914C0957, US914C0958, USD13C0031, USD13C0033, USD13C0034, USD13C0035, USD13C0036, USD13C0064, USD13C0065, USD13C0066, USD13C0067, USD13C0068, USD13C0140, USD13C0141, USD13C0142, USD13C0195, USD13C0230, USD13C0231, USD13C0233, USD13C0254, USD13C0257, USD13C0357, USD13C0358, USD13C0359, USD13C0360, USD13C0361, USD13C0362, USD13C0363, USD13C0371, USD13C0372, USD13C0373, USD13C0374, USD13C0375, USD13C0376, USD13C0377, USD13C0478, USD13C0479, USD13C0480, USD13C0481, USD13C0729, USD14C0108, USD14C0109, USD14C0110, USD14C0111, USD14C0114, USD14C0117, USD14C0277, USD14C0278, USD14C0279, USD14C0281, USD14C0284, USD14C0285, USD14C0288, USD14C0289, USD14C0368, USD14C0369, USD14C0400, USD14C0527, USD14C0661, USD14C0662, USD14C0663, USD14C0664, USD14C0669, USD14C0670, USD14C0761, USN13C0014, USN13C0015, USN13C0016, USN13C0017, USN13C0018, USN13C0040, USN13C0041, USN13C0042, USN13C0043, USN13C0044, USN13C0045, USN13C0046, USN13C0047, USN13C0048, USN13C0049, USN13C0050, USN13C0051, USN13C0052, USN13C0053, USN13C0075, USN13C0076, USN13C0077, USN13C0078, USN13C0151, USN13C0152, USN13C0205, USN13C0206, USN13C0277, USN13C0278, USN13C0279, USN13C0280, USN13C0360, USN13C0361, USN13C0393, USN13C0456, USN13C0457, USN13C0460, USN13C0469, USN13C0499, USN13C0501, USN13C0502, USN13C0532, USN13C0573, USN13C0579, USN13C0580, USN13C0593, USN13C0622, USN13C0623, USN13C0624, USN13C0625, USN13C0627, USN13C0652, USN13C0653, USN13C0654, USN13C0655, USN13C0656, USN13C0657, USN13C0658, USN14C0030, USN14C0101, USN14C0102, USN14C0104, USN14C0311, USN14C0365, USN14C0469, USN14C0470, USN14C0601, USN14C0655, USN14C0936, USN14C0937, USN14C0938, USN14C0940, USN14C0941, USN14C1040, USN14C1041, USN14C1042, USO13C0361, USO13C0396, USO13C0397, USO13C0399, USO13C0400, USO13C0401, USO13C0402, USO13C0403, USO13C0453, USO13C0454, USO13C0465, USO13C0470, USO13C0471, USO13C0472, USO13C0473, USO13C0553, USO13C0593, USO13C0629, USO13C0678, USO13C0680, USO13C0681, USO13C0682, USO13C0683, USO13C0685, USO14C0051, USO14C0052, USO14C0053, USO14C0096, USO14C0125, USO14C0185, USO14C0186, USO14C0187, USO14C0478, USO14C0601, USO14C0602, USO14C0603, USO14C0604, USO14C0605, USO14C0606, USO14C0721, USO14C0845, USO14C1091, USO14C1124, USO14C1125, USO14C1126, USO14C1127, and USO14C1180.
Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.
751 units total (246 units in the US and 505 units outside the US)