EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Cata...
FDA Device Recall #Z-1578-2015 — Class II — April 10, 2015
Recall Summary
| Recall Number | Z-1578-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 10, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Ultrasound, Inc. |
| Location | Bothell, WA |
| Product Type | Devices |
| Quantity | 751 units total (246 units in the US and 505 units outside the US) |
Product 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)
Reason for Recall
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).
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.
Lot / Code Information
*********************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, 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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.
Other Recalls from Philips Ultrasound, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1757-2024 | Class II | 5000 Compact Series Ultrasound Systems, Product... | Mar 23, 2024 |
| Z-0283-2024 | Class II | Philips EPIQ Diagnostic Ultrasound System Model... | Oct 9, 2023 |
| Z-0284-2024 | Class II | Philips Affiniti 70, Diagnostic Ultrasound Syst... | Oct 9, 2023 |
| Z-2517-2023 | Class II | 3D9-3v Transducer, accessory to Philips Ultraso... | Jun 30, 2023 |
| Z-1380-2016 | Class II | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5... | Mar 28, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.