Z-1400-2012

TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland...

Name: Z-1400-2012 TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland...
Creator: Scottcare Corporation
Published: 2012-01-19
License: https://open.fda.gov/license/

Scottcare Corporation / initiated 2012-01-19 / Terminated / root cause: design

FDA source

Scottcare Corporation began a recall of TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. The TeleSentry device is intended for diagnostic... on 2012-01-19. The reason FDA records is "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". 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-1400-2012
Status: Terminated
Initiated: 2012-01-19
Posted: 2012-04-13
Terminated: 2013-09-27
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.
Product code: DSI Detector And Alarm, Arrhythmia
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 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.

Product code DSI

K092947Class IITelesentry, Model Ts01Scottcare Corporation / cleared 2010-02-26

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)