Siemens Medical Solutions USA, Inc.

Model number 8717741.

Radiology Devices

2

No

Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam

Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.

Model numbers: 8717733, 10275007, 10275008, 10275009 and 10275010.

Radiology Devices

2

No

Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam

Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

Model numbers: 10764801, 10764802, 10764803 and 10764804.

Radiology Devices

2

No

Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam

Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

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, 9023, 9024, 9026, 9027, 9028, 9029, 9030, 9031, 9032, 9033, 9034, 9035, 9036, 9037, 9038, 9039, 9041, 9043, 8473046345, 8503, 8205, 8505, 8506, 8509, 8510, 8511, 8513, 8514, 8515, 8516, 8517, 8518, 8519, 8520, 9821, 8501, 8501*, 8502, 8507, 8508, 10000, 10001, 10002, 10003, 10005, 10006, 10007, 10008, 10009, 10010, 10013, 10014, 10015, 10016, 10017, 10019, 10020, 10022, 10023, 10024, 10025, 10026, 10028, 10029, 10030, 10031, 10032, 10033, 10034, 10035, 10036, 10037, 10038, 10040, 10041, 10042, 10044, 10046, 10047, 10048, 10049, 10050, 10051, 10052, 10053, 10054, 10055, 10056, 10057, 10058, 10059, 10060, 10061, 10062, 10063, 10065, 10066, 10067, 10068, 10069, 10070, 10071, 10072, 10073, 10074, 10076, 10077, 10078, 10079, 10080, 10082, 10083, 10084, 10085, 10087, 10088, 10089, 10090, 10091, 10092, 10093, 10094, 10096, 10098, 10099, 10100, 10101, 10102, 10103, 10104, 10106, 10107, 10108, 10109, 10111, 10112, 10113, 10114, 10115, 10117, 10118, 10119, 10120, 10121, 10122, 10124, 10125, 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.

Radiology Devices

2

No

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.

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.

e.cam systems that were refurbished from 04/06/15 to 10/06/15. Material number 10151531, serial number 70004; Material number 10151532 serial numbers 70038, 70040, 70041, 70042, 70043, 70044, 70039, 70045, and 70046.

Radiology Devices

2

No

Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.

The e.cam Dual Signature Gamma Camera system. Used 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.