Z-0353-2020 Class II Terminated
FDA device recall Z-0353-2020 was initiated by Heritage Medical Products, Inc. on September 2, 2016 and is designated Class II. Reason for recall: Potential for bed to drop suddenly at the head while a patient is laying on it. The recall status is terminated (terminated December 14, 2020). Affected quantity: 167 beds (159 US, 8 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- September 2, 2016
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 beds (159 US, 8 OUS)
Product Description
2000 Vascular with 30 Degree option
Reason for Recall
Potential for bed to drop suddenly at the head while a patient is laying on it.
Distribution Pattern
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.
Code Information
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.