—#136055

Product

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)

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K132304
Affected lot / code info: *********************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, 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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, 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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.

Why it was recalled

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).

Root cause (FDA determination)

Software design

Action the firm took

Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 and Ultrasound system letter, dated 2015 APRIL 10, and the Urgent-Medical Device Correction-Philips Model EPIQ7 and Ultrasound system letter, dated 2015 APRIL 10, letters to their consignees. These systems WITH Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500336 for EPIQ5 -FCO 79500337 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.

Timeline

Recall initiated: 2015-04-10
Posted by FDA: 2015-05-05
Terminated: 2016-02-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.