Events

Retiro De Equipo (Recall) de c.cam Gamma Camera

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    44913
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0304-2008
  • Fecha de inicio del evento
    2007-09-17
  • Fecha de publicación del evento
    2007-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-01-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64526
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Tomography System (Emission Computed) - Product Code KPS
  • Causa
    Unintended motion: a hardware fault in the c.Cam system can cause the system to experience unintended motion, thereby causing a collision hazard.
  • Acción
    Urgent Field Correction Recall letters dated 9/11/07, on Siemens letter head were sent to the end users via U.S. certified mail, informing them of the potential risk of unintended motion of the detector head resulting in a collision hazard. The end users were warned not to press any of the detection motion buttons while simultaneously holding the collision over ride button on the c.cam hand controller, and were provided steps to take if the system stops during an acquisition and displays the Collision Error message. They were told that a Siemens service representative will contact them within 90 days to schedule the repair of the c.cam at no cost to the end user. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens office at: 1-800-888-7436 (USA).

Device

c.cam Gamma Camera
  • Modelo / Serial
    Model No: 9VIR1200/Serial Numbers: 1001, 1002, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032, 1033, 1034, 1036, 1037, 1038, 1039, 1040, 1041, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1052, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094, 1095, 1096, 1097, 1098, 1099, 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1113, 1114, 1115, 1116, 1117, 1118, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1147, 1148, 1149, 1150, 1151, 1152, 1153, 1154, 1155, 1156, 1157, 1158, 1159, 1160, 1161, 1162, 1163, 1164, 1165, 1166, 1168, 1169, 1170, 1171, 1172, 1173, 1174, 1175, 1176, 1177, 1178, 1179, 1180, 1181, 1182, 1183, 1184, 1185, 1186, 1187, 1188, 1189, 1190, 1191, 1192, 1193, 1194, 1195, 1196, 1197, 1198, 1199, 1200, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1208, 1209, 1210, 1211, 1212, 1213, 1214, 1215, 1216, 1217, 1218, 1219, 1220, 1221, 1222, 1223, 1224, 1225, 1226, 1227, 1228, 1229, 1231, 1232, 1233, 1234, 1235, 1236, 1237, 1238, 1239, 1241, 1242, 1243, 1245, 1246, 1247, 1248, 1249, 1250, 1251, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1259, 1260, 1261, 1262, 1263, 1265, 1266, 1267, 1268, 1270, 1271, 1272, 1273, 1274, 1275, 1276, 1278, 1279, 1280, 1281, 1282, 1283, 1285, 1286, 1287, 1288, 1289, 1290, 1291, 1292, 1294, 1295, 1296, 1297, 1298, 1299, 1300, 1301, 1302, 1303, 1305, 1306, 1307, 1308, 1309, 1310, 1311, 1312, 1313, 1314, 1315, 1316, 1317, 1318, 1319, 1320, 1321, 1322, 1323, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1342, 1343, 1345, 1346, 1347, 1348, 1350, 1351, 1352, 1353, 1354, 1355, 1356, 1357, 1358, 1359, 1360, 1361, 1362, 1363, 1365, 1366, 1367, 1368, 1369, 1370, 1371, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1385, 1386, 1387, 1388, 1389, 1390, 1391, 1392, 1393, 1394, 1395, 1396, 1397, 1398, 1399, 1400, 1401, 1402, 1403, 1405, 1406, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1423, 1425, 1426, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1440, 1441, 1442, 1443, 1445, 1446, 1447, 1448, 1449, 1450, 1451, 1452, 1453, 1454, 1455, 1456, 1457, 1458, 1460, 1461, 1462, 1463, 1465, 1466, 1467, 1468, 1469, 1470, 1471, 1472, 1473, 1474, 1475, 1476, 1477, 1478, 1479, 1480, 1481, 1482, 1483, 1485, 1486, 1487, 1489, 1490, 1491, 1492, 1493, 1494, 1495, 1496, 1498, 1499, 1500, 1501, 1502, 1503, 1504, 1505, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1517
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA including Puerto Rico and Brazil, Canada, France, Germany, Great Britain, Israel, The Netherlands, and Portugal.
  • Descripción del producto
    c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA