Events

Rappel de Device Recall Siemens Medical Solutions, Inc.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Medical Solutions USA, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72296
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0208-2016
  • Date de mise en oeuvre de l'événement
    2015-06-26
  • Date de publication de l'événement
    2015-11-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140495
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, tomography, computed, emission - Product Code KPS
  • Cause
    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.
  • Action
    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.
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60192-2061
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA