Events

Recall of Device Recall VECTRA GENISYS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Chattanooga Corp Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    47428
  • Event Risk Class
    Class 2
  • Event Number
    Z-1636-2008
  • Event Initiated Date
    2008-02-28
  • Event Date Posted
    2008-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69551
  • Notes / Alerts
    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.
  • Extra notes in the data
    electromechanical therapeutic ultrasound device - Product Code IMI
  • Reason
    Device may fail to administer therapy during use.
  • Action
    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.

Device

Device Recall VECTRA GENISYS
  • Model / Serial
    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
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.
  • Manufacturer
    Chattanooga Corp Inc

Manufacturer

Chattanooga Corp Inc
  • Manufacturer Address
    Chattanooga Corp Inc, 4717 Adams Rd, Hixson TN 37343
  • Source
    USFDA