Class 2 Device Recall TeleSentry, Multiparameter Ambulatory Telemetry

• Date Initiated by Firm: January 19, 2012
• Date Posted: April 13, 2012
• Recall Status: Terminated 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/ Manufacturer: 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: 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