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U.S. Department of Health and Human Services

Class 2 Device Recall TeleSentry, Multiparameter Ambulatory Telemetry

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  Class 2 Device Recall TeleSentry, Multiparameter Ambulatory Telemetry see related information
Date Initiated by Firm January 19, 2012
Date Posted April 13, 2012
Recall Status1 Terminated 3 on September 27, 2013
Recall Number Z-1400-2012
Recall Event ID 61370
510(K)Number K092947  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product 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.
Code Information 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.
Recalling Firm/
Scottcare Corporation
4791 W 150th St
Cleveland OH 44135-3301
For Additional Information Contact Timothy J. Leyva
216-362-0550 Ext. 113
Manufacturer Reason
for Recall
Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.
FDA Determined
Cause 2
Component design/selection
Action ScottCare sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 19, 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to immediately discontinue use and quarantine any affected products. A Recall Acknowledgement Form was enclosed for customers to complete and return via fax to (216) 257-6129. Contact the firm at (216) 362-0550 ext. 113 for questions regarding this recall.
Quantity in Commerce 513 units
Distribution Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, MI, NJ, NV, NY, OH, PA and TX, and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = SCOTTCARE CORPORATION