Recall of Device Recall TeleSentry, Multiparameter Ambulatory Telemetry

Model #TS01, Part #101086, Serial #s: DV10Y01B1987, DV10Y01B1624, DV10Y01B1686, DV10Y01B1747, DV10Y01B1780, DV10Y01B1967, DV10Y01B1268, DV10Y01B1268, DV10Y01B0032, DV10Y01B0119, DV10Y01B0335, DV10Y01B0502 DV10Y01B0505, DV10Y01B0692, DV10Y01B0780, DV10Y01B0825, DV10Y01B0880, DV10Y01B0989, DV10Y01B0992, DV10Y01B1157, DV10Y01B1408, DV10Y01B1497, DV10Y01B1499, DV10Y01B1500, DV10Y01B1531, DV10Y01B1559, DV10Y01B1583, DV10Y01B1594, DV10Y01B1597, DV10Y01B1602, DV10Y01B1605, DV10Y01B1660, DV10Y01B1721, DV10Y01B1739, DV10Y01B1800, DV10Y01B1802, DV10Y01B1817, DV10Y01B1827, DV10Y01B1847, DV10Y01B1874, DV10Y01B1886, DV10Y01B1938, DV10Y01B1954, DV10Y01B1965, DV10Y01B1968, DV10Y01B1972, DV10Y01B1980, DV10Y01B1999, DV10Y01B2000, DV10Y01B0086, DV10Y01B1513, DV10Y01B1551, DV10Y01B1568, DV10Y01B1579, DV10Y01B1695, DV10Y01B1723, DV10Y01B1745, DV10Y01B1791, DV10Y01B1825, DV10Y01B1826, DV10Y01B1868, DV10Y01B1873, DV10Y01B1879, DV10Y01B1884, DV10Y01B1903, DV10Y01B1926, DV10Y01B1931, DV10Y01B1937, DV10Y01B1956, DV10Y01B1960, DV10Y01B1970, DV10Y01B1977, DV10Y01B1979, DV10Y01B1996, DV10Y01B0003, DV10Y01B0715, DV10Y01B0957, DV10Y01B0988, DV10Y01B1502, DV10Y01B1520, DV10Y01B1556, DV10Y01B1563, DV10Y01B1566, DV10Y01B1585, DV10Y01B1592, DV10Y01B1630, DV10Y01B1647, DV10Y01B1674, DV10Y01B1694, DV10Y01B1733, DV10Y01B1765, DV10Y01B1787, DV10Y01B1799, DV10Y01B1803, DV10Y01B1823, DV10Y01B1835, DV10Y01B1838, DV10Y01B1843, DV10Y01B1865, DV10Y01B1893, DV10Y01B1894, DV10Y01B1902, DV10Y01B1955, DV10Y01B1994, DV10Y01B1852, DV10Y01B1880, DV10Y01B1885, DV10Y01B1890, DV10Y01B1636, DV10Y01B1684, DV10Y01B1705, DV10Y01B1860, DV10Y01B1863, DV10Y01B1729, DV10Y01B1925, DV10Y01B0746, DV10Y01B1572, DV10Y01B1575, DV10Y01B1608, DV10Y01B1637, DV10Y01B1655, DV10Y01B1735, DV10Y01B1737, DV10Y01B1755, DV10Y01B1775, DV10Y01B1830, DV10Y01B0450, DV10Y01B0600, DV10Y01B0631, DV10Y01B0662, DV10Y01B0685, DV10Y01B0748, DV10Y01B0845, DV10Y01B0914, DV10Y01B0915, DV10Y01B0949, DV10Y01B0950, DV10Y01B0963, DV10Y01B0990, DV10Y01B0996, DV10Y01B1009, DV10Y01B1498, DV10Y01B1501, DV10Y01B1503, DV10Y01B1506, DV10Y01B1516, DV10Y01B1517, DV10Y01B1519, DV10Y01B1521, DV10Y01B1523, DV10Y01B1524, DV10Y01B1525, DV10Y01B1527, DV10Y01B1530, DV10Y01B1532, DV10Y01B1533, DV10Y01B1534, DV10Y01B1540, DV10Y01B1541, DV10Y01B1542, DV10Y01B1543, DV10Y01B1545, DV10Y01B1547, DV10Y01B1548, DV10Y01B1550, DV10Y01B1552, DV10Y01B1555, DV10Y01B1557, DV10Y01B1558, DV10Y01B1560, DV10Y01B1561, DV10Y01B1562, DV10Y01B1564, DV10Y01B1565, DV10Y01B1567, DV10Y01B1570, DV10Y01B1571, DV10Y01B1574, DV10Y01B1588, DV10Y01B1595, DV10Y01B1596, DV10Y01B1598, DV10Y01B1599, DV10Y01B1604, DV10Y01B1607, DV10Y01B1609, DV10Y01B1610, DV10Y01B1611, DV10Y01B1615, DV10Y01B1619, DV10Y01B1621, DV10Y01B1622, DV10Y01B1623, DV10Y01B1625, DV10Y01B1626, DV10Y01B1627, DV10Y01B1633, DV10Y01B1635, DV10Y01B1642, DV10Y01B1646, DV10Y01B1648, DV10Y01B1649, DV10Y01B1652, DV10Y01B1658, DV10Y01B1663, DV10Y01B1664, DV10Y01B1665, DV10Y01B1670, DV10Y01B1676, DV10Y01B1678, DV10Y01B1681, DV10Y01B1683, DV10Y01B1687, DV10Y01B1688, DV10Y01B1690, DV10Y01B1691, DV10Y01B1693, DV10Y01B1696, DV10Y01B1697, DV10Y01B1698, DV10Y01B1701, DV10Y01B1703, DV10Y01B1707, DV10Y01B1708, DV10Y01B1710, DV10Y01B1711, DV10Y01B1712, DV10Y01B1714, DV10Y01B1715, DV10Y01B1717, DV10Y01B1719, DV10Y01B1726, DV10Y01B1727, DV10Y01B1728, DV10Y01B1730, DV10Y01B1734, DV10Y01B1738, DV10Y01B1740, DV10Y01B1752, DV10Y01B1754, DV10Y01B1757, DV10Y01B1760, DV10Y01B1763, DV10Y01B1764, DV10Y01B1767, DV10Y01B1769, DV10Y01B1770,. DV10Y01B1771, DV10Y01B1772, DV10Y01B1773, DV10Y01B1776, DV10Y01B1777, DV10Y01B1778, DV10Y01B1779, DV10Y01B1782, DV10Y01B1785, DV10Y01B1786, DV10Y01B1793, DV10Y01B1806, DV10Y01B1809, DV10Y01B1811, DV10Y01B1812, DV10Y01B1816, DV10Y01B1818, DV10Y01B1821, DV10Y01B1822, DV10Y01B1829, DV10Y01B1831, DV10Y01B1832, DV10Y01B1836, DV10Y01B1840, DV10Y01B1844, DV10Y01B1846, DV10Y01B1849, DV10Y01B1851, DV10Y01B1853, DV10Y01B1855, DV10Y01B1857, DV10Y01B1859, DV10Y01B1861, DV10Y01B1862, DV10Y01B1864, DV10Y01B1867, DV10Y01B1869, DV10Y01B1878, DV10Y01B1882, DV10Y01B1888, DV10Y01B1896, DV10Y01B1898, DV10Y01B1900, DV10Y01B1901, DV10Y01B1904, DV10Y01B1906, DV10Y01B1908, DV10Y01B1911, DV10Y01B1912, DV10Y01B1913, DV10Y01B1914, DV10Y01B1917, DV10Y01B1918, DV10Y01B1919, DV10Y01B1920, DV10Y01B1922, DV10Y01B1927, DV10Y01B1928, DV10Y01B1930, DV10Y01B1932, DV10Y01B1933, DV10Y01B1935, DV10Y01B1939, DV10Y01B1940, DV10Y01B1941, DV10Y01B1942, DV10Y01B1943, DV10Y01B1944, DV10Y01B1945, DV10Y01B1947, DV10Y01B1949, DV10Y01B1951, DV10Y01B1952, DV10Y01B1957, DV10Y01B1958, DV10Y01B1959, DV10Y01B1961, DV10Y01B1962, DV10Y01B1963, DV10Y01B1964, DV10Y01B1969, DV10Y01B1976, DV10Y01B1981, DV10Y01B1982, DV10Y01B1983, DV10Y01B1985, DV10Y01B1986, DV10Y01B1988, DV10Y01B1989, DV10Y01B1990, DV10Y01B1992, DV10Y01B1993, DV10Y01B1995, DV10Y01B1998, DV10Y01B1515, DV10Y01B1554, DV10Y01B1692, DV10Y01B1720, DV10Y01B1864, DV10Y01B1616, DV10Y01B1732, DV10Y01B1916, DV10Y01B0982, DV10Y01B1549, DV10Y01B1569, DV10Y01B1724, DV10Y01B1731, DV10Y01B1751, DV10Y01B1948, DV10Y01B1553, DV10Y01B1871, DV10Y01B1514, DV10Y01B1529, DV10Y01B1704, DV10Y01B1866, DV10Y01B1883, DV10Y01B1950, DV10Y01B1953, DV10Y01B0048, DV10Y01B0193, DV10Y01B0620, DV10Y01B0991, DV10Y01B0995, DV10Y01B1273, DV10Y01B1504, DV10Y01B1507, DV10Y01B1522, DV10Y01B1539, DV10Y01B1546, DV10Y01B1606, DV10Y01B1634, DV10Y01B1644, DV10Y01B1651, DV10Y01B1657, DV10Y01B1673, DV10Y01B1699, DV10Y01B1709, DV10Y01B1716, DV10Y01B1743, DV10Y01B1762, DV10Y01B1766, DV10Y01B1784, DV10Y01B1792, DV10Y01B1805, DV10Y01B1807, DV10Y01B1808, DV10Y01B1828, DV10Y01B1833, DV10Y01B1842, DV10Y01B1845, DV10Y01B1870, DV10Y01B1875, DV10Y01B1881, DV10Y01B1887, DV10Y01B1891, DV10Y01B1923, DV10Y01B1978, DV10Y01B1984, DV10Y01B0255, DV10Y01B1510, DV10Y01B1512, DV10Y01B1518, DV10Y01B1544, DV10Y01B1576, DV10Y01B1578, DV10Y01B1586, DV10Y01B1614, DV10Y01B1628, DV10Y01B1638, DV10Y01B1643, DV10Y01B1645, DV10Y01B1685, DV10Y01B1689, DV10Y01B1748, DV10Y01B1750, DV10Y01B1781, DV10Y01B1795, DV10Y01B1856, DV10Y01B0565, DV10Y01B1535, DV10Y01B1537, DV10Y01B1584, DV10Y01B1629, DV10Y01B1659, DV10Y01B1662, DV10Y01B1666, DV10Y01B1669, DV10Y01B1768, DV10Y01B1801, DV10Y01B1804, DV10Y01B1573, DV10Y01B1587, DV10Y01B1653, DV10Y01B1858, DV10Y01B1872, DV10Y01B1877, DV10Y01B1921, DV10Y01B1929, DV10Y01B1934, DV10Y01B1936, DV10Y01B1975, DV10Y01B1577, DV10Y01B1617, DV10Y01B1971, DV10Y01B1850, DV10Y01B1834, DV10Y01B0036, DV10Y01B0117, DV10Y01B0160, DV10Y01B0531, DV10Y01B0593, DV10Y01B0994, DV10Y01B1508, DV10Y01B1526, DV10Y01B1581, DV10Y01B1590, DV10Y01B1593, DV10Y01B1600, DV10Y01B1618, DV10Y01B1679, DV10Y01B1706, DV10Y01B1744, DV10Y01B1753, DV10Y01B1783, DV10Y01B1788, DV10Y01B1798, DV10Y01B1820, DV10Y01B1841, DV10Y01B1974, DV10Y01B0533, DV10Y01B1997, DV10Y01B0019, DV10Y01B0941, DV10Y01B1115, DV10Y01B1224, DV10Y01B1528, DV10Y01B1603, DV10Y01B1656, DV10Y01B1667, DV10Y01B1713, DV10Y01B1722, DV10Y01B1725, DV10Y01B1854, DV10Y01B1876, DV10Y01B1889, DV10Y01B1897, DV10Y01B1899, DV10Y01B1905, DV10Y01B1907, DV10Y01B1910, DV10Y01B1915, DV10Y01B1924, DV10Y01B1946, DV10Y01B1966, DV10Y01B0030, DV10Y01B1505, DV10Y01B1509, DV10Y01B1511, DV10Y01B1536, DV10Y01B1538, DV10Y01B1580, DV10Y01B1582, DV10Y01B1589, DV10Y01B1591, DV10Y01B1601, DV10Y01B1612, DV10Y01B1613, DV10Y01B1620, DV10Y01B1631, DV10Y01B1632, DV10Y01B1639, DV10Y01B1640, DV10Y01B1650, DV10Y01B1654, DV10Y01B1661, DV10Y01B1668, DV10Y01B1671, DV10Y01B1672, DV10Y01B1675, DV10Y01B1677, DV10Y01B1680, DV10Y01B1682, DV10Y01B1700, DV10Y01B1702, DV10Y01B1718, DV10Y01B1736, DV10Y01B1741, DV10Y01B1742, DV10Y01B1746, DV10Y01B1749, DV10Y01B1756, DV10Y01B1758, DV10Y01B1759, DV10Y01B1774, DV10Y01B1789, DV10Y01B1790, DV10Y01B1794, DV10Y01B1796, DV10Y01B1797, DV10Y01B1810, DV10Y01B1813, DV10Y01B1814, DV10Y01B1815, DV10Y01B1819, DV10Y01B1824, DV10Y01B1837, DV10Y01B1839, DV10Y01B1848, DV10Y01B1895, DV10Y01B1909, DV10Y01B1973, DV10Y01B1991, DV10Y01B1641, & DV10Y01B1761.

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, MI, NJ, NV, NY, OH, PA and TX, and the country of Canada.

TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. || The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.