FDA Device

VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.

Hazard

Device may fail to administer therapy during use.

What You Should Do

Remedy

Chattanooga Group sent an Urgent Medical Device Recall letter dated 02/29/2008 to consignees to advise them of problem and the recall. The first group of letters was sent to the distributors via certified mail. The letter stated that the devices were failing and the recall was to the User level. The firm is recalling the devices for repair and calibration. The firm followed with a user notification, by US Mail not certified beginning on March 11, 2008.

Products

VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.
Brand
Chattanooga Corp Inc
UPC
Serial numbers: 1000, 1002, 1003, 1004, 1005, 1007, 1008, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1021, 1025, 1026, 1028, 1029, 1030, 1031, 1032, 1034, 1035, 1036, 1037, 1039, 1040, 1042, 1043, 1044, 1045, 1046, 1047, 1050, 1051, 1054, 1056, 1058, 1059, 1060, 1061, 1062, 1064, 1066, 1067, 1069, 1071, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1081, 1082, 1083, 1085, 1086, 1087, 1088, 1089, 1091, 1095, 1096, 1097, 1100, 1102, 1103, 1112, 1114, 1120, 1121, 1122, 1123, 1124, 1125, 1130, 1135, 1137, 1138, 1141, 1142, 1143, 1145, 1146, 1147, 1148, 1149, 1150, 1153, 1157, 1158, 1162, 1163, 1168, 1169, 1171, 1176, 1177, 1178, 1180, 1181, 1186, 1191, 1193, 1194, 1195, 1196, 1197, 1198, 1200, 1201, 1203, 1206, 1207, 1208, 1209, 1210, 1211, 1213, 1215, 1216, 1217, 1220, 1221, 1222, 1225, 1226, 1227, 1228, 1229, 1231, 1232, 1233, 1235, 1236, 1237, 1238, 1239, 1240, 1241, 1247, 1248, 1249, 1254, 1255, 1256, 1259, 1261, 1262, 1266, 1269, 1273, 1275, 1277, 1278, 1279, 1280, 1281, 1282, 1283, 1285, 1286, 1289, 1291, 1293, 1294, 1295, 1296, 1300, 1301, 1302, 1303, 1304, 1305, 1307, 1308, 1309, 1310, 1313, 1314, 1319, 1320, 1329, 1330, 1333, 1339, 1341, 1344, 1346, 1348, 1349, 1351, 1359, 1360, 1361, 1362, 1363, 1364, 1369, 1370, and 1373

Units Affected

207 devices