Scottcare Corporation: 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.

Recall number

Z-1400-2012

Recalling firm

Scottcare Corporation

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.

Status

Terminated

Initiated

2012-01-19

Posted

2012-04-13

Terminated

2013-09-27

Reason

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.

Root 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

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.

Lot, serial or model codes

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.

510(k) numbers

["K092947"]

PMA numbers

not on file

Product code

DSI

Firm FEI

1527715

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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