Events

Device Recall Siemens Medical Solutions, Inc. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, 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
    72296
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0208-2016
  • 사례 시작날짜
    2015-06-26
  • 사례 출판 날짜
    2015-11-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140495
  • 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, tomography, computed, emission - Product Code KPS
  • 원인
    Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. the redesigned brake redundancy circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.
  • 조치
    The firm, Siemens, sent out an undated "CUSTOMER SAFETY ADVISORY NOTICE" on 04 April 2015 to its consignees informing them of the e.com system safety update. The notice described the product, problem and actions to be taken. The notice stated the following: In order for an injury to occur, the following series of events must be present; 1. The detector configuration angle must be 180 degrees. 2. The detector with the failed brake circuit must be above the patient. 3. The detector with the faulty brake circuit must be under power (in motion). 4. System power must cycle within a very short time period, preventing the brake circuit from charging. The customers were instructed to continue to use their e.com system and to ensure the safety advisory is placed in the systems instructions for use and to observe patients while system is in use. If they experience difficulty or failure while performing the daily touch pad test, they are advised to discontinue use and contact their local representative. If unintended movement is detected they are advised to remove the patient and discontinue using the system and contact their local service representative. If you have any questions regarding this important safety notice, please contact your local Service representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121 Local Service representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121

Device

Device Recall Siemens Medical Solutions, Inc.
  • 모델명 / 제조번호(시리얼번호)
    E.cam Model numbers affected : 4380213, 4380221, 5242826, 5077066, 5077074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7760161, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10520745. This recall applies only to ecam systems that were installed before December 31st 2004.  Serial Numbers 7438, 7440, 81010, 1011, 8509, 8510, 1, 1007, 1008, 1010, 1019, 1020, 2001, 2004, 2006, 2007, 2009, 2010, 2014, 2017, 2019, 2022, 2023, 2025, 3002, 3006, 3008, 3010, 3011, 3012, 3013, 3014, 3017, 3021, 3022, 3023, 3024, 3029, 3031, 3034, 4001, 4002, 4004, 4008, 4009, 4010, 4011, 4013, 4014, 4016, 1006, 1009, 1015, 1016, 1020, 1021, 1024, 1025, 1029, 1030, 1031, 1032, 1033, 1041, 1044, 1046, 1051, 1056, 1057, 1063, 1068, 1069, 1070, 1071, 10711, 1074, 1076, 1077, 1079, 1084, 1092, 1095, 1096, 1098, 1100, 1102, 1105, 1106, 1111, 1116, 1117, 1118, 1122, 1123, 1124, 1127, 1130, 1132, 1133, 1134, 1135, 1136, 1137, 1142, 1143, 1146, 1148, 1150, 1151, 1153, 1155, 1157, 1158, 1160, 1161, 1162, 1163, 1165, 1166, 1169, 1172, 1174, 1176, 1180, 1181, 1182, 1184, 1186, 1187, 1188, 1189, 1190, 1191, 1192, 1196, 1197, 1199, 1200, 12009, 1201, 1202, 1205, 1206, 1207, 1208, 121010, 1211, 1234, 126110, 21909, 26011, 31609, 31711, 31827, 41207, 62111, 62310, 7030, 71410, 71411, 7440, 7502, 7582, 8149, 82409, 9, 918073, 1002, 1006, 1009, 1013, 1014, 1015, 1016, 1019, 1020, 1021, 1024, 1029, 1034, 1036, 1037, 1038, 1039, 1046, 1049, 1052, 1056, 1058, 1059, 1062, 1063, 1065, 1067, 1071, 1077, 1080, 1081, 1082, 1083, 1088, 1089, 1094, 1095, 1099, 1101, 1103, 1104, 1105, 1107, 1109, 1110, 1113, 1114, 1116, 1118, 1121, 1129, 1130, 1131, 1135, 1136, 1137, 1138, 1139, 1141, 1142, 1143, 2001, 2004, 2006, 2007, 2008, 2010, 2012, 2013, 2014, 2015, 2017, 2019, 2024, 2026, 2027, 2028, 2030, 2036, 2038, 2039, 2041, 2042, 2045, 2047, 2048, 2050, 2051, 2052, 2055, 2058, 2060, 2065, 2066, 2074, 2075, 2076, 2078, 2079, 2080, 2081, 2084, 2090, 2096, 2098, 2099, 2100, 2107, 2114, 2115, 2117, 2118, 2119, 2120, 2122, 2123, 2124, 2125, 2127, 2128, 2130, 3004, 3005, 3007, 3008, 3010, 3015, 3016, 3018, 3020, 3022, 3023, 3026, 3027, 3029, 3032, 3035, 3037, 3039, 3040, 3045, 3047, 3048, 3049, 3050, 3051, 3052, 3055, 3056, 3057, 3058, 3064, 3065, 3067, 3069, 3070, 3071, 3075, 3076, 3077, 3080, 3082, 3083, 3085, 3087, 3088, 3090, 3091, 3092, 3093, 3094, 3096, 3098, 3100, 3101, 3104, 3105, 3106, 3107, 3109, 3112, 3114, 3115, 3116, 3117, 3118, 3120, 3121, 3122, 3123, 3124, 3125, 3132, 3133, 3135, 3137, 3138, 3139, 3140, 3141, 4001, 4002, 4004, 4006, 4007, 4008, 4010, 4011, 4012, 4014, 4015, 4017, 4018, 4019, 4021, 4022, 4023, 4024, 4025, 4026, 4028, 4030, 4034, 4039, 4041, 4044, 4045, 4048, 4049, 4050, 4052, 4053, 4054, 4056, 4057, 4060, 4062, 4063, 4064, 4066, 4067, 4068, 4069, 4070, 4071, 4076, 4077, 4078, 4090, 10209, 10411, 12210, 12310, 31611, 40109, 4082, 4083, 4084, 4086, 4095, 4096, 4097, 4098, 4100, 4107, 4112, 4114, 4116, 4117, 4118, 4119, 4120, 4121, 4122, 4125, 4127, 4129, 4130, 4131, 4132, 4135, 4136, 4137, 4141, 4142, 4143, 4146, 4147, 4148, 4149, 4151, 4152, 4154, 4156, 4158, 4159, 4164, 4166, 4168, 4171, 4173, 4174, 4177, 4178, 4179, 4181, 4182, 4183, 4185, 4186, 4190, 4196, 4197, 4202, 4205, 4206, 4208, 4209, 4214, 4215, 4217, 4218, 4219, 4220, 4221, 4222, 4223, 4225, 4226, 5001, 5002, 5004, 5005, 5006, 5008, 5009, 5011, 5012, 5013, 5016, 5017, 5018, 5019, 5020, 5021, 5022, 5023, 5024, 5025, 5027, 5029, 5031, 5032, 5033, 5036, 5037, 5039, 5040, 5041, 5042, 5043, 5045, 5046, 5048, 5049, 5050, 5051, 5057, 5060, 5063, 5067, 5069, 5070, 5071, 5102, 5107, 5108, 5117, 5123, 6000, 60911, 62211, 83110, 83210, 92110, 4017, 4018, 4019, 4022, 4023, 4025, 4030, 4032, 4033, 4034, 4035, 4037, 4044, 4046, 4049, 5001, 5003, 5004, 5006, 5007, 5008, 5010, 5011, 5012, 5013, 5015, 5016, 5017, 5018, 5020, 5021, 5022, 5024, 5025, 5028, 5031, 5033, 5036, 5037, 5039, 5040, 5043, 3, 6006, 6007, 6009, 6010, 7001, 7004, 7006, 7409, 7501, 7502, 7507, 7509, 6053, 6501, 7386, 7502, 7504, 7505, 7507, 7508, 7510, 7512, 7513, 7515, 7516, 7517, 7518, 7519, 7520, 7521, 7522, 7523, 7525, 7526, 7529, 7531, 7533, 7534, 7535, 7536, 7538, 7539, 7540, 7542, 7545, 7547, 7548, 7549, 7550, 7551, 7553, 7555, 7556, 7557, 7558, 7561, 7562, 7563, 7564, 7566, 7568, 7569, 7573, 7574, 7576, 7577, 7578, 7579, 7581, 7582, 7584, 7587, 7588, 7589, 7590, 7592, 7595, 7596, 7599, 7600, 7602, 7605, 7606, 7608, 7610, 7611, 7614, 7615, 7616, 7617, 7618, 7618*, 7620, 7621, 7622, 7623, 7624, 7626, 7627, 7628, 7629, 7631, 7635, 7636, 7637, 7638, 7651, 7861, 8001, 8003, 8005, 8006, 8007, 8009, 8010, 8011, 8014, 8015, 8017, 8020, 8021, 8023, 8024, 8025, 8027, 8028, 8029, 8030, 8031, 8032, 8035, 8036, 8037, 8039, 8040, 8044, 8045, 8047, 8049, 8050, 8051, 8053, 8055, 8056, 8057, 8058, 8059, 8060, 8063, 8064, 8067, 8069, 8070, 8071, 8072, 8073, 8075, 8078, 8079, 8080, 8081, 8082, 8085, 8087, 8088, 8089, 8090, 8092, 8094, 8095, 8096, 8097, 8098, 8099, 8100, 8102, 8105, 8106, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119, 8120, 8121, 8122, 8124, 8125, 8126, 8127, 8128, 8130, 8131, 8132, 8133, 8135, 8137, 8138, 8141, 8142, 8144, 8145, 8146, 8147, 8501, 8502, 8503, 8504, 8505, 8506, 8508, 8510, 8511, 8512, 8513, 8514, 8515, 8516, 8517, 8518, 8519, 8520, 8521, 8522, 8523, 8524, 8525, 8526, 8527, 8528, 8529, 8530, 8532, 8533, 8534, 8535, 8536, 8538, 8540, 8541, 8543, 8544, 8545, 8548, 8549, 8550, 8552, 8553, 8556, 8558, 8559, 8560, 8561, 8562, 8563, 8564, 8565, 8567, 8568, 8569, 8570, 8571, 8572, 8573, 8574, 8575, 8576, 8577, 8578, 8580, 8581, 8583, 8585, 8586, 8587, 8588, 8589, 8590, 8592, 8593, 8595, 8596, 8598, 8600, 8603, 8604, 8605, 8606, 8607, 8608, 8609, 8610, 8611, 8612, 8613, 8615, 8616, 8617, 8618, 8619, 8620, 8621, 8622, 8624, 8625, 8626, 8628, 8629, 8630, 8631, 8632, 8633, 8634, 8635, 8636, 8637, 8638, 8639, 8640, 8641, 8642, 8643, 8645, 8646, 8647, 8650, 8651, 8652, 8653, 8654, 8655, 8656, 8657, 8658, 8659, 8660, 8661, 8662, 8665, 8666, 8667, 8668, 8669, 8670, 8671, 8672, 8673, 8674, 8675, 8676, 8677, 8678, 8679, 8681, 8683, 8684, 8685, 8686, 8687, 8688, 8689, 8690, 8691, 8692, 8693, 8694, 8695, 8696, 8697, 8698, 8699, 8700, 8701, 8702, 8703, 8704, 8705, 8706, 8707, 8708, 8709, 8710, 8711, 8712, 8714, 8716, 8717, 8718, 8719, 8720, 8721, 8722, 8723, 8724, 8725, 8726, 8727, 8728, 8729, 8730, 8731, 8732, 8733, 8734, 8735, 8736, 8738, 8739, 8740, 8741, 8743, 8744, 8745, 8746, 8747, 8748, 8749, 8750, 8754, 8755, 8756, 8757, 8758, 8759, 8760, 8761, 8763, 8766, 8767, 8769, 8770, 8771, 8773, 8778, 8779, 8780, 8781, 8782, 8783, 8784, 8786, 8788, 8789, 8790, 8791, 8792, 8793, 8794, 8799, 8801, 8802, 8803, 8804, 8805, 8807, 8808, 8809, 8810, 8811, 8812, 8813, 8814, 8816, 8817, 8818, 8819, 8820, 8822, 8823, 8824, 8825, 8827, 8828, 8829, 8830, 8831, 8832, 8833, 8834, 8835, 8836, 8837, 8838, 8839, 8841, 8842, 8844, 5045, 7502, 7503, 7505, 7506, 7509, 7511, 8001, 8003, 8004, 8007, 8009, 8010, 8012, 8013, 8014, 8015, 8016, 8017, 8019, 8021, 8022, 8024, 8025, 8027, 8028, 8030, 8032, 8501, 8503, 8504, 8506, 8507, 8508, 8509, 8511, 8512, 8513, 8514, 8517, 8518, 8519, 8521, 8523, 8524, 8525, 8526, 8528, 8530, 8532, 8534, 8535, 8536, 8537, 8539, 8540, 8543, 8545, 8547, 8548, 8549, 8550, 8552, 8553, 8554, 8555, 8556, 7090, 7502, 7504, 7505, 8001, 8003, 8005, 8021, 8501, 8502, 8503, 8504, 8505, 8506, 1001, 13044, 5039, 5505, 5507, 5508, 5510, 5511, 5512, 5514, 5517, 5518, 5519, 5521, 5522, 5523, 5524, 5525, 5526, 5527, 5528, 5529, 5530, 5531, 5532, 5533, 5535, 5536, 5537, 5538, 5539, 5540, 5541, 5542, 5546, 5547, 5548, 5550, 5551, 5553, 5555, 5556, 5557, 5558, 5559, 5560, 5561, 5562, 5563, 5565, 5567, 5570, 5571, 5572, 5573, 5575, 5578, 5579, 5580, 5581, 5584, 5585, 5586, 5587, 5588, 5589, 5590, 5591, 5593, 5594, 5595, 5597, 5599, 5600, 5601, 5602, 5603, 5604, 5605, 5606, 5607, 5608, 5609, 5610, 5611, 5612, 5613, 5614, 5616, 5617, 5618, 5620, 5622, 5623, 5624, 5625, 5629, 5631, 5632, 5634, 5636, 5637, 5639, 5640, 5642, 5644, 5645, 5646, 5647, 5649, 5650, 5658, 5671, 5672, 5673, 5674, 5675, 5676, 5677, 5678, 5679, 7005, 7006, 7007, 7009, 7011, 7012, 7013, 7014, 7016, 7017, 7018, 7019, 7020, 7022, 7025, 7027, 7028, 7029, 7030, 7031, 7032, 7033, 7034, 7036, 7037, 7039, 7040, 7041, 7043, 7044, 7045, 7046, 7047, 7048, 7049, 7050, 7051, 7056, 7058, 7059, 7060, 7061, 7062, 7063, 7065, 7067, 7068, 7069, 7070, 7073, 7076, 7078, 7080, 7082, 7083, 7084, 7086, 7088, 7090, 7091, 7092, 7094, 7095, 7096, 7097, 7098, 7102, 7103, 7104, 7105, 7109, 7110, 7111, 7112, 7117, 7120, 7121, 7124, 7126, 7127, 7501, 7502, 7503, 7504, 7505, 7506, 7508, 7509, 7510, 7512, 7513, 7515, 7516, 7517, 7519, 7520, 7521, 7523, 7524, 7525, 7526, 7530, 7531, 7532, 7533, 7534, 7535, 7536, 7537, 7538, 7539, 7541, 7544, 7545, 7551, 7552, 7553, 7555, 7556, 7557, 7560, 7561, 7562, CAX271/U2B004, 5501, 5502, 5503, 5506, 5511, 5512, 5513, 5514, 5516, 5517, 5519, 5521, 5523, 5525, 5526, 5527, 5529, 7003, 7004, 7005, 7006, 7008, 7011, 7013, 7015, 7017, 7018, 7019, 7020, 7021, 7022, 7024, 7025, 7026, 7501, 7504, 7506, 7507, 7508, 7509, 7513, 5101, 5102, 5104, 5109, 5110, 5112, 5113, 5115, 5116, 5118, 5121, 5125, 5126, 5127, 5128, 5131, 5132, 5133, 5135, 5136, 5142, 5144, 5146, 5147, 5148, 5149, 5150, 5151, 5153, 5157, 5158, 5159, 5160, 5162, 5165, 5167, 5168, 5170, 5171, 5172, 5173, 5174, 5502, 1003, 548, 550, 558, 564, 579, 581, 588, 589, 590, 592, 593, 595, RC528, RC537, RC549, 551, 584, RC521, RC536, 10610, 21511, 510, 529, 530, 557, 559, 573, 62310, RC498, RC543, 556, 572, RC493, RC524, RC538, RC541, RC545, RC546, 8501, 8503, 8504, 8505, 8506, 8508, 8509, 8510, 8511, 100003, 1234, 1234578, 4916, 60151, 63010, 7409, 7502, 8191, 8501, 8502, 8503, 8506, 8507, 8508, 8509, 8512, 8514, 8515, 8517, 8519, 8520, 8521, 8522, 8523, 8524, 8525, 8529, 8530, 8531, 8532, 8533, 8534, 8537, 8538, 8539, 8540, 8541, 8542, 8543, 8544, 8546, 8547, 8548, 8549, 8550, 8551, 8552, 8553, 8554, 8555, 8556, 8557, 8560, 8561, 8562, 8563, 8564, 8565, 8566, 8567, 8568, 8569, 8570, 8571, 8572, 8573, 8574, 8577, 8578, 8579, 8580, 8581, 8583, 9003, 9004, 9006, 9007, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9022, 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10126, 10127, 10128, 10129, 10130, 10131, 10132, 10133, 10135, 10136, 10137, 10138, 10139, 10140, 10141, 10142, 10143, 10144, 10147, 10149, 10150, 10151, 10153, 10154, 10155, 10156, 10157, 10158, 10159, 10160, 10161, 10162, 10163, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10173, 10174, 10175, 10176, 10177, 10178, 10179, 10180, 10181, 10182, 10183, 10184, 10185, 10186, 10187, 10188, 10191, 10192, 10193, 10194, 10195, 10198, 10199, 10200, 10201, 10202, 10203, 10204, 10205, 10206, 10207, 10208, 10209, 10211, 10212, 10213, 10214, 10215, 10216, 10217, 10218, 10219, 10220, 10221, 10222, 10224, 10225, 10226, 10227, 10228, 10230, 10231, 10232, 10233, 10234, 10235, 10236, 10237.10238, 10239, 10240, 10241, 10243, 10245, 10246, 10248, 10249, 10250, 10251, 10252, 10253, 10254, 10255, 10256, 10257, 10258, 10259, 10260, 10261, 10262, 10263, 10264, 10265, 10266, 10267, 10268, 10269, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10280, 10282, 10283, 10284, 10285, 10286, 10287, 10288, 10289, 10290, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10306, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10326, 10327, 10328, 10329, 10330, 10331, 10332, 10333, 10334, 10336, 10337, 10338, 10339, 10340, 10341, 10343, 10344, 5382, 5517, 5764, 8490, 9001, 9002, 9003, 9004, 9005, 9006, 9008, 9009, 9010, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9022, 9023, 9024, 9025, 9026, 9027, 9028, 9031, 9033, 9034, 9035, 9036, 9038, 9039, 9040, 9041, 9043, 9044, 9045, 9046, 9047, 9049, 9050, 9051, 9053, 9054, 9055, 9057, 9058, 9059, 9060, 9061, 9062, 9063, 9064, 9066, 9068, 9069, 9070, 9073, 9074, 9076, 9077, 9078, 9079, 9080, 9081, 9082, 9083, 9084, 9085, 9086, 9087, 9089, 9090, 9091, 9092, 9094, 9095, 9096, 9097, 9098, 9099, 9100, 9101, 9102, 9103, 9104, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9120, 9122, 9123, 9124, 9125, 9126, 9127, 9129, 9130, 9132, 9133, 9134, 9135, 9136, 9137, 9138, 9139, 9142, 9143, 9144, 9145, 9146, 9147, 9148, 9149, 9150, 9151, 9152, 9154, 9155, 9156, 9157, 9158, 9159, 9161, 9162, 9163, 9164, 9165, 9166, 9167, 9169, 9170, 9171, 9172, 9173, 9174, 9175, 9176, 9177, 9179, 9180, 9181, 9182, 9183, 9184, 9185, 9186, 9187, 9189, 9190, 9191, 9193, 9194, 9198, 9199, 9200, 9201, 9204, 9206, 9207, 9210, 9212, 9213, 9214, 9215, 9216, 9219, 9220, 9221, 9223, 9224, 9225, 9226, 9227, 9228, 9230, 9231, 9232, 9233, 9234, 9235, 9238, 9239, 9240, 9241, 9242, 9243, 9245, 9246, 9247, 9248, 9251, 9252, 9253, 9254, 9255, 9256, 9259, 9260, 9261, 9262, 9263, 9264, 9265, 9266, 9267, 9268, 9269, 9270, 9271, 9272, 9273, 9274, 9275, 9276, 9277, 9279, 9280, 9281, 9282, 9283, 9284, 9285, 9287, 9288, 9289, 9290, 9292, 9293, 9294, 9295, 9296, 9297, 9298, 9299, 9300, 9301, 9302, 9303, 9304, 9305, 9306, 9307, 9308, 9309, 9311, 9313, 10001, 10002, 10003, 10004, 10005, 10006, 10007, 10008, 10009, 10011, 10012, 10014, 10015, 10016, 10017, 10018, 10019, 10022, 10023, 10025, 10026, 10027, 10028, 10029, 10030, 10031, 10032, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10044, 10045, 10046, 10047, 10048, 10049, 10050, 10051, 10052, 10055, 10056, 10057, 10058, 10059, 10061, 8505, 8509, 9001, 9002, 9003, 9004, 9005, 9007, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9019, 9020, 9021, 9022, 9024, 9026, 9031, 9032, 9033, 9034, 9036, 9037, 9038, 9039, 9040, 9041, 9042, 9043, 9044, 9045, 9001, 9002, 9005, 9006, 9007, 9009, 9010, 9011, 9013, 9014, 9016, and 9017.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, Cameroon, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominica, Ecuador, Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Croatia, Canary Islands, Ireland, Israel, India, Iraq, Iran, Islamic-Republic of, Italy, Jordan, Japan, Korea-Republic of, Kuwait, Lebanon, Sri Lanka, Luxembourg, Latvia, Morocco, Myanmar, Mauritius, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Russian Federation, Saudi Arabia, Sweden, Slovakia, El Salvador, Syrian Arab Republic (Syria), Thailand, Tunisia, Turkey, Taiwan, Republic of China, Ukraine, Uganda, Uzbekistan, and South Africa.
  • 제품 설명
    e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60192-2061
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA