Z-1638-2008

VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No...

Name: Z-1638-2008 VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No...
Creator: Chattanooga Corp Inc
Published: 2008-02-28
License: https://open.fda.gov/license/

Chattanooga Corp Inc / initiated 2008-02-28 / Terminated / root cause: design

FDA source

Chattanooga Corp Inc began a recall of VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2761, Chattanooga Group on 2008-02-28. The reason FDA records is "Device may fail to administer therapy during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1638-2008
Status: Terminated
Initiated: 2008-02-28
Posted: 2008-08-06
Terminated: 2010-02-19
Recalling firm: Chattanooga Corp Inc
Product: VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2761, Chattanooga Group.
Product code: IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Reason for recall: Device may fail to administer therapy during use.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 479 devices
Distribution: Nationwide Distribution.
Product codes and lots: Serial numbers: 1037, 1038, 1041, 1042, 1045, 1049, 1050, 1055, 1056, 1061, 1062, 1063, 1064, 1066, 1067, 1068, 1071, 1073, 1074, 1075, 1076, 1117, 1119, 1122, 1123, 1124, 1128, 1129, 1130, 1131, 1132, 1133, 1135, 1137, 1138, 1139, 1140, 1141, 1143, 1144, 1145, 1146, 1148, 1149, 1150, 1153, 1155, 1156, 1207, 1208, 1209, 1212, 1215, 1222, 1223, 1224, 1226, 1228, 1229, 1230, 1231, 1232, 1233, 1234, 1235, 1236, 1238, 1240, 1242, 1244, 1245, 1247, 1248, 1250, 1251, 1253, 1254, 1256, 1257, 1258, 1260, 1262, 1265, 1266, 1362, 1364, 1365, 1366, 1370, 1372, 1374, 1375, 1377, 1378, 1381, 1382, 1383, 1384, 1413, 1414, 1415, 1416, 1417, 1421, 1422, 1424, 1425, 1427, 1428, 1429, 1430, 1433, 1434, 1435, 1436, 1464, 1467, 1468, 1470, 1472, 1473, 1474, 1480, 1481, 1485, 1486, 1487, 1489, 1491, 1492, 1493, 1494, 1495, 1497, 1499, 1500, 1502, 1503, 1504, 1505, 1507, 1508, 1509, 1510, 1563, 1565, 1570, 1573, 1574, 1578, 1579, 1586, 1612, 1613, 1615, 1616, 1616, 1617, 1618, 1619, 1620, 1625, 1626, 1627, 1630, 1632, 1634, 1635, 1636, 1638, 1639, 1642, 1643, 1644, 1645, 1667, 1668, 1669, 1670, 1672, 1673, 1675, 1677, 1679, 1680, 1683, 1685, 1737, 1738, 1741, 1742, 1743, 1744, 1745, 1746, 1747, 1748, 1749, 1753, 1754, 1755, 1756, 1757, 1759, 1761, 1762, 1763, 1764, 1765, 1767, 1775, 1776, 1777, 1779, 1780, 1784, 1785, 1787, 1788, 1789, 1790, 1791, 1818, 1819, 1820, 1821, 1822, 1826, 1828, 1830, 1832, 1834, 1835, 1836, 1838, 1840, 1846, 1847, 1848, 1852, 1853, 1855, 1857, 1858, 1861, 1862, 1864, 1865, 1867, 1868, 1869, 1870, 1872, 1874, 1876, 1878, 1881, 1882, 1887, 1889, 1891, 1892, 1894, 1898, 1900, 1902, 1954, 1956, 1957, 1961, 1964, 1965, 1967, 1972, 1975, 1976, 1977, 1979, 1980, 1983, 1985, 1989, 1990, 1992, 1995, 1996, 1997, 1998, 2000, 2001, 2005, 2007, 2008, 2011, 2012, 2013, 2014, 2017, 2018, 2019, 2020, 2025, 2028, 2036, 2037, 2039, 2041, 2118, 2128, 2129, 2131, 2133, 2136, 2139, 2141, 2144, 2145, 2146, 2148, 2150, 2152, 2156, 2158, 2160, 2162, 2163, 2164, 2166, 2168, 2170, 2172, 2175, 2177, 2181, 2186, 2187, 2197, 2198, 2199, 2201, 2203, 2205, 2207, 2211, 2214, 2217, 2222, 2223, 2224, 2227, 2230, 2237, 2239, 2240, 2241, 2246, 2248, 2253, 2254, 2256, 2259, 2260, 2290, 2293, 2295, 2296, 2298, 2303, 2376, 2378, 2381, 2383, 2384, 2391, 2392, 2393, 2394, 2396, 2397, 2398, 2399, 2401, 2402, 2404, 2407, 2411, 2412, 2414, 2417, 2419, 2425, 2432, 2435, 2436, 2439, 2445, 2446, 2448, 2453, 2457, 2458, 2461, 2464, 2469, 2475, 2478, 2481, 2482, 2490, 2494, 2498, 2505, 2575, 2727, 2731, 2735, 2740, 2747, 2750, 2756, 2763, 2776, 2778, 2779, 2784, 2792, 2793, 2796, 2814, 2815, 2816, 2819, 2867, 2889, 2892, 2898, 2982, 2988, 2989, 2990, 2994, 2995, 2999, 3000, 3003, 3005, 3006, 3008, 3009, 3011, 3013, 3014, 3015, 3018, 3021, 3083, 3092, and 3102

Product code IMG

K031077Class IIVectra Epr System and Intelect Epr SystemChattanooga Group / cleared 2003-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)