BEUDAMED
    FDA Enforcement Class II Terminated

    2000 Vascular with 30 Degree option

    Recall: Z-0353-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0353-2020
    Event ID
    83219
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heritage Medical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 20, 2019
    Initiation Date
    September 2, 2016
    Classification Date
    November 8, 2019
    Termination Date
    December 14, 2020
    Address
    10380 County Road 6310, N/A, West Plains, MO, 65775-6331, United States

    Description

    2000 Vascular with 30 Degree option

    Reason

    Potential for bed to drop suddenly at the head while a patient is laying on it.

    Code Info

    Serial Numbers: 2030, 1713, 1041, 1191, 1368, 1306, 2052, 1895, 1554, 1618, 1511, 1990, 1659, 2279, 1354, 1547, 1442, 2156, 1536, 1471, 1472, 1473, 1548, 1549, 1550, 1551, 1750, 1242, 1601, 2008, 1946, 1947, 1868, 1865, 1811, 1831, 1832, 2202, 1495, 2082, 2083, 1044, 1571, 1621, 2017, 2203, 2121, 2145, 2054, 1016, 1017, 2284, 1876, 2278, 1039, 1685, 1686,1043, 1307, 1357,2224, 2225, 1852, 1297, 2122, 2123, 1439, 1629, 2059, 1648, 1470, 1046, 1941, 1942, 1943, 1944, 1962, 1421, 885, 887, 1234, 1387, 1388, 1389, 1390, 1391, 1392, 1414, 1447, 1796, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 2004, 1838, 1597, 1707, 1266, 1449, 1513, 1514,1515, 1516, 1661, 1998, 1380, 2094, 1221, 881, 886, 1058, 1095, 1189, 1243, 1267, 1377, 1379, 1399, 1400, 1420, 1453, 1458, 1477, 1498, 1527, 1581, 1608, 1616, 1617, 1654, 1676, 1677, 1785, 1814, 1872, 1904, 1905, 1906, 1907, 1917, 1918, 1961, 1973, 1974, 1975, 1984, 1985, 1999, 2000, 2001, 2002, 2012, 2013, 2014, 2029, 2046, 2055, 2056, 2057, 2063, 1708, 1793, 1794.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, OH, OK, OR, PA, SC, TX, UT, VA, WI, WY, PR. International distribution to Canada, Saudi Arabia, Trinidad & Tobago.

    Quantity

    167 beds (159 US, 8 OUS)