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.

Recall details

Manufacturer

Siemens Medical Solutions USA, Inc.

Distributor

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.

Lot

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,

Risk classification

Class II

Area (FDA)

device

Country

United States