EPIQ 7 Ultrasound System iwth Pediatric Cardiology option 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Ultrasound, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71084
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1579-2015
  • 사례 시작날짜
    2015-04-10
  • 사례 출판 날짜
    2015-05-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-02-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    When epiq 7 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).
  • 조치
    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.

Device

  • 모델명 / 제조번호(시리얼번호)
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US215B0682, US215B0683, US215B0684, US215B0685, US215B0686, US215B0707, US215B0720, US215B0760, US215B0761, US215B0762, US215B0857, US215B0858, US215B0859, US215B0894, US215B0895, US215B0940, US215B0941, US215B0942, US215B1023, US215B1024, US215B1025, US215B1026, US215B1031, US314B0010, US314B0011, US314B0014, US314B0016, US314B0062, US314B0063, US314B0093, US314B0140, US314B0171, US314B0175, US314B0238, US314B0261, US314B0262, US314B0263, US314B0264, US314B0265, US314B0267, US314B0268, US314B0319, US314B0393, US314B0394, US314B0395, US314B0422, US314B0487, US314B0492, US314B0493, US314B0494, US314B0540, US314B0541, US314B0542, US314B0543, US314B0544, US314B0555, US314B0556, US314B0741, US314B0769, US314B0770, US314B0771, US314B0796, US314B0841, US314B0842, US314B0843, US314B0844, US314B0845, US314B0846, US315B0043, US315B0044, US315B0046, US315B0082, US315B0083, US414B0005, US414B0006, US414B0007, US414B0008, US414B0009, US414B0010, US414B0011, US414B0030, US414B0031, US414B0032, US414B0033, US414B0041, US414B0043, US414B0059, US414B0060, US414B0064, US414B0071, US414B0106, US414B0107, US414B0108, US414B0196, US414B0206, US414B0210, US414B0224, US414B0225, US414B0226, US414B0227, US414B0228, US414B0258, US414B0259, US414B0260, US414B0261, US414B0262, US414B0263, US414B0264, US414B0296, US414B0297, US414B0298, US414B0299, US414B0304, US414B0305, US414B0306, US414B0330, US414B0379, US414B0380, US414B0381, US414B0382, US414B0383, US414B0394, US414B0419, US414B0425, US414B0521, US414B0523, US414B0524, US414B0531, US414B0552, US414B0554, US414B0555, US414B0580, US513B0192, US513B0192, US513B0223, US513B0296, US513B0321, US513B0325, US513B0392, US513B0414, US513B0622, US514B0003, US514B0040, US514B0041, US514B0073, US514B0074, US514B0075, US514B0076, US514B0077, US514B0078, US514B0079, US514B0080, US514B0110, US514B0114, US514B0144, US514B0148, US514B0243, US514B0271, US514B0318, US514B0326, US514B0331, US514B0332, US514B0334, US514B0335, US514B0337, US514B0366, US514B0367, US514B0368, US514B0370, US514B0416, US514B0420, US514B0421, US514B0424, US514B0425, US514B0471, US514B0487, US514B0491, US514B0494, US514B0495, US514B0549, US514B0550, US514B0551, US514B0552, US514B0553, US514B0554, US514B0555, US514B0556, US514B0557, US514B0583, US514B0591, US514B0592, US514B0634, US514B0659, US514B0673, US514B0675, US514B0677, US514B0678, US514B0679, US514B0680, US514B0681, US514B0720, US514B0725, US613B0033, US613B0034, US613B0101, US613B0122, US613B0275, US613B0324, US613B0325, US614B0012, US614B0019, US614B0020, US614B0021, US614B0022, US614B0121, US614B0149, US614B0237, US614B0240, US614B0241, US614B0247, US614B0285, US614B0286, US614B0287, US614B0313, US614B0314, US614B0315, US614B0330, US614B0382, US614B0416, US614B0429, US614B0430, US614B0431, US614B0436, US614B0462, US614B0510, US614B0511, US614B0512, US614B0585, US614B0586, US614B0600, US614B0614, US614B0665, US614B0685, US614B0686, US614B0731, US614B0811, US614B0812, US614B0910, US614B0912, US614B0913, US614B0914, US713B0123, US714B0005, US714B0011, US714B0048, US714B0051, US714B0055, US714B0056, US714B0057, US714B0066, US714B0104, US714B0126, US714B0155, US714B0159, US714B0160, US714B0182, US714B0184, US714B0185, US714B0187, US714B0188, US714B0191, US714B0192, US714B0193, US714B0194, US714B0195, US714B0196, US714B0197, US714B0198, US714B0214, US714B0215, US714B0216, US714B0241, US714B0242, US714B0244, US714B0245, US714B0246, US714B0247, US714B0282, US714B0285, US714B0321, US714B0322, US714B0356, US714B0359, US714B0362, US714B0363, US714B0364, US714B0365, US714B0367, US714B0403, US714B0432, US714B0433, US714B0434, US714B0456, US714B0514, US714B0578, US714B0579, US714B0583, US714B0668, US714B0669, US813B0130, US813B0228, US813B0229, US814B0021, US814B0022, US814B0059, US814B0069, US814B0070, US814B0071, US814B0072, US814B0073, US814B0106, US814B0107, US814B0130, US814B0132, US814B0133, US814B0161, US814B0162, US814B0163, US814B0181, US814B0183, US814B0188, US814B0189, 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USD13B0785, USD14B0026, USD14B0027, USD14B0028, USD14B0029, USD14B0030, USD14B0031, USD14B0032, USD14B0033, USD14B0034, USD14B0035, USD14B0036, USD14B0037, USD14B0038, USD14B0039, USD14B0104, USD14B0105, USD14B0106, USD14B0255, USD14B0256, USD14B0344, USD14B0346, USD14B0347, USD14B0348, USD14B0349, USD14B0350, USD14B0352, USD14B0501, USD14B0502, USD14B0503, USD14B0504, USD14B0586, USD14B0591, USD14B0592, USD14B0594, USD14B0595, USD14B0596, USD14B0644, USD14B0645, USD14B0646, USD14B0654, USD14B0655, USD14B0656, USD14B0657, USD14B0768, USD14B0769, USD14B0770, USD14B0771, USD14B0772, USD14B0773, USD14B0774, USD14B0775, USD14B0776, USD14B0777, USD14B0779, USD14B0780, USD14B0781, USD14B0867, USD14B0868, USD14B0869, USD14B0870, USD14B0871, USD14B0872, USD14B0874, USD14B0875, USD14B0876, USD14B0890, USD14B0943, USD14B0951, USD14B0952, USD14B0953, USD14B0954, USD14B0955, USD14B0956, USD14B0957, USD14B0962, USD14B0963, USD14B0964, USD14B0994, USD14B0997, USD14B0998, USD14B0999, USD14B1000, USD14B1001, USD14B1002, USD14B1003, USD14B1004, USD14B1005, USD14B1006, USD14B1031, USD14B1032, USD14B1034, USN13B0012, USN13B0159, USN13B0160, USN13B0199, USN13B0200, USN13B0203, USN13B0308, USN13B0331, USN13B0332, USN13B0346, USN13B0347, USN13B0412, USN13B0414, USN13B0415, USN13B0416, USN13B0417, USN13B0418, USN13B0423, USN13B0427, USN13B0431, USN13B0432, USN13B0434, USN13B0438, USN13B0439, USN13B0440, USN13B0465, USN13B0508, USN13B0509, USN13B0559, USN13B0560, USN13B0561, USN13B0562, USN13B0565, USN13B0588, USN13B0592, USN13B0647, USN13B0648, USN13B0650, USN14B0027, USN14B0029, USN14B0094, USN14B0096, USN14B0097, USN14B0098, USN14B0099, USN14B0174, USN14B0175, USN14B0176, USN14B0177, USN14B0178, USN14B0179, USN14B0180, USN14B0234, USN14B0236, USN14B0288, USN14B0289, USN14B0290, USN14B0291, USN14B0292, USN14B0294, USN14B0295, USN14B0296, USN14B0297, USN14B0303, USN14B0304, USN14B0327, USN14B0361, USN14B0390, USN14B0391, USN14B0392, USN14B0399, USN14B0401, USN14B0405, USN14B0448, USN14B0449, USN14B0450, USN14B0451, USN14B0452, USN14B0523, USN14B0524, USN14B0615, USN14B0642, USN14B0645, USN14B0646, USN14B0647, USN14B0648, USN14B0778, USN14B0803, USN14B0907, USN14B0932, USN14B0933, USN14B1023, USN14B1024, USN14B1031, USN14B1032, USN14B1033, USN14B1034, USN14B1035, USN14B1036, USN14B1037, USN14B1038, USN14B1039, USO13B0043, USO13B0054, USO13B0055, USO13B0064, USO13B0114, USO13B0208, USO13B0209, USO13B0247, USO13B0263, USO13B0264, USO13B0282, USO13B0325, USO13B0326, USO13B0328, USO13B0329, USO13B0330, USO13B0331, USO13B0332, USO13B0388, USO13B0389, USO13B0390, USO13B0391, USO13B0392, USO13B0393, USO13B0440, USO13B0441, USO13B0442, USO13B0443, USO13B0444, USO13B0445, USO13B0446, USO13B0447, USO13B0460, USO13B0461, USO13B0601, USO13B0603, USO13B0603, USO13B0605, USO13B0606, USO13B0607, USO13B0609, USO13B0610, USO13B0676, USO13B0677, USO14B0017, USO14B0090, USO14B0091, USO14B0092, USO14B0115, USO14B0116, USO14B0117, USO14B0118, USO14B0122, USO14B0194, USO14B0195, USO14B0196, USO14B0197, USO14B0198, USO14B0199, USO14B0200, USO14B0201, USO14B0202, USO14B0268, USO14B0274, USO14B0275, USO14B0276, USO14B0327, USO14B0329, USO14B0330, USO14B0344, USO14B0345, USO14B0346, USO14B0368, USO14B0370, USO14B0379, USO14B0403, USO14B0406, USO14B0407, USO14B0408, USO14B0446, USO14B0460, USO14B0462, USO14B0473, USO14B0474, USO14B0475, USO14B0522, USO14B0529, USO14B0530, USO14B0531, USO14B0553, USO14B0561, USO14B0563, USO14B0598, USO14B0599, USO14B0600, USO14B0650, USO14B0653, USO14B0654, USO14B0655, USO14B0656, USO14B0657, USO14B0658, USO14B0712, USO14B0714, USO14B0722, USO14B0754, USO14B0755, USO14B0756, USO14B0767, USO14B0768, USO14B0769, USO14B0771, USO14B0774, USO14B0782, USO14B0784, USO14B0800, USO14B0801, USO14B0813, USO14B0814, USO14B0815, USO14B0816, USO14B0817, USO14B0842, USO14B0918, USO14B0919, USO14B0920, USO14B0921, USO14B0922, USO14B1087, USO14B1088, USO14B1147, USO14B1148, USO14B1149, USO14B1170, USO14B1173, USO14B1174, and USO14B1175.   *****************************SYSTEM CODES IN CANADA***************  US114B0606, US114B0607, US114B0608, US114B0657, US115B0273, US115B0435, US115B0477, US115B0490, US115B0491, US214B0029, US214B0036, US214B0038, US214B0039, US214B0053, US214B0054, US214B0088, US214B0175, US214B0176, US214B0243, US215B0493, US215B0494, US215B0495, US215B0505, US215B0635, US414B0610, US414B0611, US514B0004, US614B0584, US614B0617, US614B0860, US614B0861, US714B0298, US814B0241, USD14B0240, USN14B1025, and USO14B0783.    ****************************SYSTEM CODES IN OTHER COUNTRIES******   US114B0033, US114B0034, US114B0035, US114B0036, US114B0037, US114B0038, US114B0039, US114B0040, US114B0041, US114B0055, US114B0087, US114B0088, US114B0089, US114B0093, US114B0111, US114B0112, US114B0114, US114B0115, US114B0123, US114B0124, US114B0125, US114B0127, US114B0128, US114B0129, US114B0166, US114B0185, US114B0204, US114B0266, US114B0267, US114B0270, US114B0335, US114B0398, US114B0432, US114B0469, US114B0471, US114B0473, US114B0474, US114B0475, US114B0489, US114B0493, US114B0494, US114B0508, US114B0509, US114B0539, US114B0613, US114B0614, US114B0615, US114B0619, US114B0620, US114B0621, US114B0622, US114B0656, US114B0658, US114B0694, US114B0695, US114B0696, US114B0700, US114B0703, US114B0728, US114B0729, US114B0745, US115B0038, US115B0050, US115B0088, US115B0089, US115B0091, US115B0092, US115B0132, US115B0173, US115B0174, US115B0175, US115B0202, US115B0203, US115B0204, US115B0206, US115B0208, US115B0209, US115B0210, US115B0376, US115B0381, US115B0434, US115B0436, US115B0437, US115B0442, US115B0443, US115B0475, US115B0476, US115B0479, US115B0484, US115B0485, US115B0487, US115B0488, US115B0489, US115B0518, US115B0521, US115B0522, US115B0523, US115B0524, US115B0525, US115B0596, US115B0597, US115B0651, US115B0652, US115B0653, US115B0654, US115B0655, US115B0661, US214B0002, US214B0003, US214B0004, US214B0027, US214B0028, US214B0037, US214B0080, US214B0083, US214B0091, US214B0092, US214B0093, US214B0094, US214B0096, US214B0097, US214B0137, US214B0146, US214B0164, US214B0165, US214B0193, US214B0194, US214B0195, US214B0196, US214B0198, US214B0396, US214B0397, US214B0399, US214B0402, US214B0403, US214B0404, US214B0432, US214B0435, US214B0436, US214B0437, US214B0438, US214B0439, US214B0440, US214B0441, US214B0445, US214B0446, US214B0447, US214B0461, US214B0462, US214B0463, US214B0464, US214B0465, US214B0466, US214B0467, US214B0468, US214B0469, US214B0470, US214B0471, US214B0472, US214B0474, US214B0519, US214B0530, US214B0532, US214B0551, US214B0580, US215B0017, US215B0018, US215B0019, US215B0020, US215B0022, US215B0023, US215B0024, US215B0025, US215B0026, US215B0042, US215B0043, US215B0044, US215B0075, US215B0093, US215B0094, US215B0095, US215B0110, US215B0111, US215B0181, US215B0182, US215B0183, US215B0184, US215B0186, US215B0187, US215B0202, US215B0203, US215B0204, US215B0205, US215B0206, US215B0207, US215B0208, US215B0289, US215B0290, US215B0291, US215B0292, US215B0293, US215B0299, US215B0335, US215B0336, US215B0337, US215B0341, US215B0342, US215B0343, US215B0362, US215B0385, US215B0388, US215B0389, US215B0390, US215B0439, US215B0441, US215B0442, US215B0443, US215B0444, US215B0445, US215B0446, US215B0447, US215B0475, US215B0506, US215B0507, US215B0520, US215B0521, US215B0523, US215B0555, US215B0559, US215B0560, US215B0561, US215B0582, US215B0583, US215B0630, US215B0680, US215B0721, US215B0724, US215B0725, US215B0846, US215B0847, US215B0848, US215B0850, US215B0861, US215B0892, US215B0900, US215B0901, US215B0902, US215B0903, US215B0904, US215B0905, US215B0906, US215B0907, US215B0908, US215B0909, US215B0910, US215B0936, US215B0938, US215B0939, US215B1022, US215B1027, US215B1029, US215B1030, US314B0006, US314B0007, US314B0008, US314B0009, US314B0056, US314B0057, US314B0058, US314B0059, US314B0060, US314B0064, US314B0065, US314B0066, US314B0096, US314B0097, US314B0098, US314B0202, US314B0203, US314B0220, US314B0221, US314B0222, US314B0223, US314B0224, US314B0225, US314B0226, US314B0227, US314B0228, US314B0229, US314B0266, US314B0272, US314B0273, US314B0274, US314B0275, US314B0276, US314B0277, US314B0278, US314B0279, US314B0280, US314B0281, US314B0304, US314B0308, US314B0309, US314B0310, US314B0311, US314B0312, US314B0313, US314B0314, US314B0315, US314B0316, US314B0317, US314B0318, US314B0340, US314B0341, US314B0342, US314B0343, US314B0344, US314B0345, US314B0346, US314B0347, US314B0348, US314B0349, US314B0350, US314B0351, US314B0352, US314B0353, US314B0354, US314B0355, US314B0356, US314B0357, US314B0378, US314B0379, US314B0380, US314B0381, US314B0382, US314B0383, US314B0384, US314B0385, US314B0386, US314B0387, US314B0388, US314B0389, US314B0390, US314B0391, US314B0392, US314B0406, US314B0407, US314B0408, US314B0409, US314B0410, US314B0411, US314B0412, US314B0413, US314B0414, US314B0449, US314B0450, US314B0451, US314B0452, US314B0453, US314B0454, US314B0455, US314B0456, US314B0457, US314B0458, US314B0459, US314B0460, US314B0461, US314B0491, US314B0495, US314B0496, US314B0497, US314B0498, US314B0499, US314B0500, US314B0501, US314B0502, US314B0545, US314B0546, US314B0547, US314B0548, US314B0549, US314B0550, US314B0551, US314B0552, US314B0553, US314B0554, US314B0615, US314B0616, US314B0617, US314B0618, US314B0619, US314B0620, US314B0621, US314B0622, US314B0623, US314B0624, US314B0625, US314B0626, US314B0627, US314B0628, US314B0629, US314B0630, US314B0631, US314B0684, US314B0685, US314B0686, US314B0687, US314B0688, US314B0689, US314B0690, US314B0691, US314B0692, US314B0693, US314B0694, US314B0695, US314B0696, US314B0697, US314B0698, US314B0699, US314B0700, US314B0701, US314B0718, US314B0719, US314B0720, US314B0721, US314B0722, US314B0723, US314B0724, US314B0725, US314B0726, US314B0727, US314B0734, US314B0735, US314B0736, US314B0737, US314B0738, US314B0739, US314B0740, US314B0767, US314B0768, US314B0805, US314B0806, US314B0807, US314B0808, US314B0836, US314B0837, US314B0838, US314B0840, US315B0036, US315B0039, US315B0040, US315B0041, US315B0042, US315B0060, US315B0061, US414B0001, US414B0004, US414B0039, US414B0040, US414B0042, US414B0061, US414B0062, US414B0073, US414B0101, US414B0102, US414B0103, US414B0104, US414B0105, US414B0141, US414B0146, US414B0147, US414B0148, US414B0149, US414B0150, US414B0151, US414B0152, US414B0153, US414B0154, US414B0197, US414B0198, US414B0199, US414B0200, US414B0201, US414B0202, US414B0204, US414B0205, US414B0207, US414B0221, US414B0222, US414B0223, US414B0229, US414B0253, US414B0254, US414B0295, US414B0300, US414B0329, US414B0331, US414B0418, US414B0453, US414B0454, US414B0455, US414B0471, US414B0472, US414B0474, US414B0475, US414B0556, US414B0557, US414B0558, US414B0559, US414B0575, US414B0576, US414B0577, US414B0578, US414B0605, US414B0607, US414B0608, US414B0612, US513B0175, US513B0194, US513B0225, US513B0265, US513B0323, US513B0391, US513B0561, US514B0005, US514B0006, US514B0007, US514B0008, US514B0009, US514B0010, US514B0011, US514B0012, US514B0013, US514B0025, US514B0039, US514B0072, US514B0112, US514B0113, US514B0145, US514B0146, US514B0233, US514B0235, US514B0236, US514B0269, US514B0315, US514B0316, US514B0317, US514B0321, US514B0325, US514B0333, US514B0363, US514B0364, US514B0490, US514B0511, US514B0512, US514B0513, US514B0514, US514B0515, US514B0585, US514B0587, US514B0588, US514B0589, US514B0627, US514B0628, US514B0629, US514B0630, US514B0633, US514B0635, US514B0658, US514B0717, US514B0721, US613B0084, US613B0102, US613B0251, US613B0302, US613B0315, US613B0316, US613B0484, US613B0485, US613B0487, US614B0013, US614B0014, US614B0015, US614B0016, US614B0017, US614B0018, US614B0068, US614B0123, US614B0148, US614B0151, US614B0152, US614B0228, US614B0235, US614B0236, US614B0246, US614B0280, US614B0281, US614B0282, US614B0283, US614B0326, US614B0327, US614B0329, US614B0410, US614B0411, US614B0432, US614B0437, US614B0438, US614B0455, US614B0457, US614B0458, US614B0459, US614B0460, US614B0461, US614B0622, US614B0630, US614B0631, US614B0632, US614B0633, US614B0634, US614B0681, US614B0687, US614B0730, US614B0734, US614B0735, US614B0736, US614B0738, US614B0739, US614B0740, US614B0741, US614B0742, US614B0775, US614B0776, US614B0799, US614B0800, US614B0801, US614B0802, US614B0803, US614B0809, US614B0814, US614B0842, US614B0843, US713B0204, US713B0205, US713B0208, US713B0532, US713B0537, US713B0573, US713B0574, US713B0575, US713B0576, US713B0577, US713B0578, US713B0579, US713B0580, US713B0590, US713B0592, US714B0004, US714B0008, US714B0009, US714B0010, US714B0038, US714B0050, US714B0061, US714B0062, US714B0063, US714B0064, US714B0101, US714B0103, US714B0105, US714B0158, US714B0229, US714B0230, US714B0238, US714B0286, US714B0318, US714B0319, US714B0320, US714B0327, US714B0360, US714B0361, US714B0366, US714B0398, US714B0401, US714B0536, US714B0537, US714B0576, US714B0641, US714B0662, US714B0693, US714B0694, US714B0695, US714B0696, US714B0717, US714B0718, US714B0719, US714B0720, US714B0721, US714B0729, US714B0730, US714B0731, US714B0732, US714B0733, US714B0734, US714B0735, US813B0015, US813B0039, US813B0161, US813B0164, US813B0183, US813B0184, US813B0185, US813B0186, US813B0187, US813B0188, US813B0189, US813B0190, US813B0191, US813B0192, US813B0193, US813B0194, US813B0396, US813B0397, US813B0398, US813B0399, US813B0400, US813B0403, US813B0404, US813B0406, US813B0407, US813B0408, US813B0409, US813B0410, US813B0411, US813B0468, US813B0469, US813B0470, US813B0471, US813B0472, US813B0473, US813B0474, US813B0475, US813B0476, US813B0477, US813B0478, US813B0479, US813B0480, US814B0014, US814B0015, US814B0016, US814B0017, US814B0020, US814B0062, US814B0063, US814B0067, US814B0101, US814B0102, US814B0103, US814B0105, US814B0129, US814B0134, US814B0158, US814B0178, US814B0262, US814B0403, US814B0404, US814B0413, US814B0414, US814B0415, US814B0420, US814B0495, US814B0496, US814B0497, US814B0498, US814B0520, US814B0522, US814B0523, US814B0529, US814B0530, US814B0531, US814B0553, US814B0558, US814B0623, US814B0624, US913B0012, US913B0014, US913B0015, US913B0028, US913B0029, US913B0030, US913B0031, US913B0032, US913B0051, US913B0085, US913B0086, US913B0131, US913B0132, US913B0133, US913B0134, US913B0135, US913B0140, US913B0141, US913B0142, US913B0143, US913B0144, US913B0183, US913B0185, US913B0201, US913B0216, US913B0217, US913B0219, US913B0220, US913B0221, US913B0222, US913B0223, US913B0257, US913B0259, US913B0260, US913B0299, US913B0300, US913B0316, US913B0317, US913B0318, US913B0319, US913B0338, US913B0359, US913B0360, US913B0459, US913B0486, US913B0499, US913B0506, US913B0565, US913B0566, US913B0567, US913B0568, US914B0008, US914B0010, US914B0011, US914B0012, US914B0025, US914B0026, US914B0027, US914B0030, US914B0046, US914B0085, US914B0086, US914B0087, US914B0088, US914B0089, US914B0090, US914B0128, US914B0132, US914B0133, US914B0135, US914B0136, US914B0137, US914B0174, US914B0192, US914B0193, US914B0194, US914B0233, US914B0234, US914B0235, US914B0270, US914B0271, US914B0272, US914B0273, US914B0274, US914B0275, US914B0339, US914B0340, US914B0381, US914B0382, US914B0383, US914B0385, US914B0386, US914B0387, US914B0411, US914B0413, US914B0538, US914B0539, US914B0541, US914B0689, US914B0692, US914B0693, US914B0777, US914B0896, US914B0897, US914B0898, US914B0905, US914B0949, US914B0950, USD13B0049, USD13B0051, USD13B0052, USD13B0056, USD13B0057, USD13B0058, USD13B0059, USD13B0062, USD13B0063, USD13B0076, USD13B0077, USD13B0078, USD13B0079, USD13B0080, USD13B0081, USD13B0082, USD13B0083, USD13B0143, USD13B0147, USD13B0148, USD13B0149, USD13B0154, USD13B0216, USD13B0242, USD13B0286, USD13B0287, USD13B0288, USD13B0300, USD13B0301, USD13B0302, USD13B0303, USD13B0304, USD13B0305, USD13B0306, USD13B0307, USD13B0353, USD13B0354, USD13B0355, USD13B0378, USD13B0379, USD13B0380, USD13B0381, USD13B0423, USD13B0436, USD13B0437, USD13B0438, USD13B0513, USD13B0514, USD13B0638, USD13B0639, USD13B0640, USD13B0641, USD13B0645, USD13B0776, USD13B0777, USD13B0779, USD13B0781, USD13B0782, USD14B0024, USD14B0090, USD14B0091, USD14B0092, USD14B0094, USD14B0095, USD14B0096, USD14B0097, USD14B0098, USD14B0099, USD14B0100, USD14B0101, USD14B0145, USD14B0146, USD14B0147, USD14B0150, USD14B0151, USD14B0152, USD14B0153, USD14B0154, USD14B0242, USD14B0244, USD14B0245, USD14B0246, USD14B0247, USD14B0248, USD14B0249, USD14B0250, USD14B0251, USD14B0252, USD14B0253, USD14B0254, USD14B0339, USD14B0340, USD14B0341, USD14B0342, USD14B0343, USD14B0384, USD14B0385, USD14B0386, USD14B0387, USD14B0388, USD14B0389, USD14B0390, USD14B0391, USD14B0392, USD14B0393, USD14B0394, USD14B0395, USD14B0396, USD14B0455, USD14B0456, USD14B0457, USD14B0462, USD14B0500, USD14B0508, USD14B0509, USD14B0510, USD14B0511, USD14B0512, USD14B0513, USD14B0514, USD14B0515, USD14B0580, USD14B0642, USD14B0647, USD14B0649, USD14B0650, USD14B0651, USD14B0652, USD14B0778, USD14B1036, USD14B1037, USD14B1038, USD14B1039, USD14B1040, USN13B0010, USN13B0011, USN13B0033, USN13B0154, USN13B0155, USN13B0156, USN13B0157, USN13B0158, USN13B0202, USN13B0232, USN13B0233, USN13B0234, USN13B0333, USN13B0343, USN13B0348, USN13B0419, USN13B0424, USN13B0425, USN13B0426, USN13B0433, USN13B0435, USN13B0464, USN13B0506, USN13B0510, USN13B0511, USN13B0512, USN13B0513, USN13B0558, USN13B0564, USN13B0567, USN13B0586, USN13B0587, USN13B0589, USN13B0641, USN13B0644, USN14B0021, USN14B0022, USN14B0023, USN14B0090, USN14B0091, USN14B0092, USN14B0093, USN14B0135, USN14B0136, USN14B0137, USN14B0138, USN14B0140, USN14B0141, USN14B0142, USN14B0169, USN14B0170, USN14B0171, USN14B0172, USN14B0173, USN14B0235, USN14B0287, USN14B0300, USN14B0301, USN14B0302, USN14B0308, USN14B0309, USN14B0328, USN14B0329, USN14B0357, USN14B0362, USN14B0387, USN14B0388, USN14B0389, USN14B0398, USN14B0400, USN14B0409, USN14B0410, USN14B0411, USN14B0439, USN14B0440, USN14B0445, USN14B0513, USN14B0514, USN14B0515, USN14B0516, USN14B0518, USN14B0521, USN14B0586, USN14B0587, USN14B0588, USN14B0589, USN14B0591, USN14B0593, 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USO13B0597, USO13B0608, USO13B0632, USO13B0642, USO13B0643, USO13B0673, USO13B0674, USO13B0675, USO14B0012, USO14B0013, USO14B0014, USO14B0015, USO14B0016, USO14B0018, USO14B0026, USO14B0043, USO14B0057, USO14B0082, USO14B0113, USO14B0133, USO14B0146, USO14B0193, USO14B0263, USO14B0265, USO14B0266, USO14B0271, USO14B0272, USO14B0273, USO14B0325, USO14B0326, USO14B0341, USO14B0461, USO14B0465, USO14B0466, USO14B0467, USO14B0468, USO14B0469, USO14B0470, USO14B0471, USO14B0472, USO14B0521, USO14B0528, USO14B0532, USO14B0549, USO14B0550, USO14B0551, USO14B0552, USO14B0557, USO14B0558, USO14B0559, USO14B0560, USO14B0591, USO14B0592, USO14B0593, USO14B0594, USO14B0595, USO14B0596, USO14B0597, USO14B0651, USO14B0652, USO14B0715, USO14B0716, USO14B0764, USO14B0765, USO14B0766, USO14B0809, USO14B0810, USO14B0811, USO14B0812, USO14B0828, USO14B0831, USO14B0834, USO14B0835, USO14B0836, USO14B0837, USO14B0838, USO14B0839, USO14B0840, USO14B0916, USO14B1086, USO14B1120, USO14B1122, USO14B1123, USO14B1130, USO14B1132, and USO14B1171.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.
  • 제품 설명
    EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: || 453561726491 (1.0) || 453561728121 (1.0.1) || 453561736781 (1.1) || 453561750021 (1.1.1) || 453561753631 (1.1.2) || 453561772251 (1.2) || 453561772631 (1.2.1) || 453561786591 (1.2.2) || 453561785101 (1.3) || 453561800601 (1.3.1) || 453561805211 (1.3.2)
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • 제조사 모회사 (2017)
  • Source
    USFDA