HillRom 405 Bed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hill-Rom, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    56018
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2168-2010
  • 사례 시작날짜
    2009-09-16
  • 사례 출판 날짜
    2010-08-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    AC-Powered Adjustable Hospital Bed - Product Code FNL
  • 원인
    The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin e-ring, which could cause the e-ring to come off.
  • 조치
    The firm sent an Urgent Field Safety Notice to its customers dated 9/16/2009. The letter identified the affected product, explained the reason for the recall, actions to be taken, and a contact reference. Customers are to locate the affected product, examine the pivot points and ensure the E-ring is present. If the E-ring is missing, then the affected bed is to be taken out of service. Customers' distributors or agents will contact them with a permanent fix. Questions should be directed towards Hill-Rom Technical Support.

Device

  • 모델명 / 제조번호(시리얼번호)
    K110HE1421, K110HE1422, K110HE1423, K110HE1424, K110HE1425, K110HE1426, K110HE1427, K110HE1428, K110HE1429, K110HE1430, K110HE1431, K110HE1432, K110HE1433, K110HE1434, K110HE1435, K110HE1436, K110HE1437, K110HE1438, K110HE1439, K110HE1440, K110HE1441, K110HE1442, K110HE1443, K110HE1444, K110HE1445, K110HE1446, K110HE1447, K110HE1448, K110HE1449, K110HE1450, K110HE1451, K110HE1452, K110HE1453, K110HE1454, K110HE1455, K110HE1456, K110HE1457, K110HE1458, K110HE1459, K110HE1460, K110HE1461, K110HE1462, K110HE1463, K110HE1464, K110HE1465, K110HE1466, K110HE1467, K110HE1468, K110HE1469, K110HE1470, K110HE1471, K110HE1472, K110HE1473, K110HE1474, J145HE0493, J144HE0452, J144HE0462, J144HE0469, J144HE0472, J145HE0476, J145HE0479, J145HE0480, J145HE0487, J145HE0488, J145HE0495, J145HE0475, J144HE0454, J144HE0455, J144HE0457, J144HE0470, J144HE0471, J145HE0474, J145HE0477, J145HE0489, J145HE0490, J145HE0494, K040HE0576, K040HE0577, K040HE0579, K040HE0580, K040HE0581, K04HE0578, J194HE0770, 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J130HE0323, J130HE0324, J130HE0325, J130HE0326, J130HE0327, J130HE0328, J130HE0329, J130HE0330, J130HE0331, J130HE0332, J130HE0333, J130HE0334, J130HE0335, J130HE0336, J130HE0337, J130HE0338, J130HE0339, J131HE0340, J131HE0341, J131HE0342, J131HE0343, J131HE0344, J131HE0345, J131HE0346, J131HE0347, J131HE0348, J131HE0349, J131HE0350, J131HE0351, J131HE0352, J131HE0353, J131HE0354, J131HE0355, J131HE0356, J131HE0357, J131HE0358, J131HE0359, J131HE0360, J131HE0361, J131HE0362, J131HE0363, J131HE0364, J138HE0367, J138HE0368, J138HE0369, J138HE0370, J138HE0371, J138HE0372, J138HE0373, J138HE0374, J138HE0375, J138HE0376, J141HE0377, J141HE0378, J141HE0379, J141HE0380, J142HE0381, J142HE0382, J142HE0383, J142HE0384, J142HE0385, J142HE0386, J142HE0387, J142HE0388, J142HE0389, J142HE0390, J142HE0391, J142HE0392, J142HE0393, J142HE0394, J142HE0395, J142HE0396, J142HE0397, J142HE0398, J142HE0399, J142HE0400, J142HE0401, J142HE0402, J142HE0403, J142HE0404, J143HE0405, J143HE0406, J143HE0407, 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K178HE2470, K178HE2471, K178HE2472, K178HE2473, K178HE2474, K178HE2475, K178HE2476, K178HE2477, K178HE2478, K178HE2479, K178HE2480, K178HE2481, K178HE2482, K178HE2483, K178HE2484, K178HE2485, K178HE2486, K178HE2487, K178HE2488, K178HE2489, K178HE2490, K178HE2491, K178HE2492, K178HE2493, K178HE2494, K178HE2495, K178HE2496, K178HE2497, K178HE2498, K178HE2499, K178HE2500, K178HE2501, K178HE2502, K178HE2503, K178HE2504, K178HE2505, K178HE2506, K178HE2507, K178HE2508, J208HE0924, J208HE0925, J208HE0926, J208HE0927, J208HE0928, K104HE1339, K104HE1340, K104HE1341, K104HE1342, K104HE1343, K104HE1344, K104HE1345, K104HE1346, K104HE1347, K104HE1348, K104HE1349, K104HE1350, K104HE1351, K104HE1352, K104HE1353, K104HE1354, K104HE1355, K104HE1356, K104HE1357, K104HE1358, K104HE1359, K104HE1360, K104HE1361, K104HE1362, K104HE1363, K104HE1364, K104HE1365, K104HE1366, K104HE1367, K104HE1368, K104HE1369, K104HE1370, K104HE1371, K104HE1372, K104HE1373, K104HE1374, K104HE1375, K104HE1376, K104HE1377, K104HE1378, K104HE1379, K104HE1380, K104HE1381, K104HE1382, J175HE0739, J308HE1936, J308HE1937, J308HE1938, J308HE1939, J308HE1940, J308HE1941, K117HE1668, K117HE1669, J099HE0140, K104HE1338, J143HE0429, J143HE0430, J143HE0431, J143HE0432, J143HE0433, J143HE0434, J143HE0435, J143HE0436, J143HE0437, J143HE0438, J143HE0439, J143HE0440, J143HE0441, J143HE0442, J143HE0443, J143HE0444, J143HE0445, J143HE0446, J143HE0447, J143HE0448, J143HE0449, J143HE0450, J143HE0451, J155HM0582, J257HE1451, J257HE1452, J257HE1453, J257HE1454, J257HE1455, J257HE1456, J257HE1457, J257HE1458, J257HE1459, J257HE1460, J257HE1461, J257HE1462, J257HE1463, J257HE1464, J257HE1465, J257HE1466, J257HE1467, J257HE1468, J257HE1469, J257HE1470, J257HE1471, J257HE1472, J257HE1473, J257HE1474, J257HE1475, J257HE1476, J257HE1477, J257HE1478, J257HE1479, J257HE1480, J257HE1481, J257HE1482, J257HE1483, J257HE1484, J257HE1485, J146HE0504, J146HE0505, J146HE0506, J146HE0507, J146HE0508, J146HE0509, J146HE0510, J146HE0511, J146HE0512, J146HE0513, J146HE0514, J146HE0515, J151HE0524, J151HE0525, J151HE0526, J151HE0527, J151HE0528, J151HE0529, J151HE0530, J151HE0531, J151HE0532, J151HE0533, J151HE0534, J151HE0535, J151HE0536, J151HE0537, J151HE0538, J151HE0539, J151HE0540, J151HE0541, J151HE0542, J151HE0543, J152HM0557, J152HM0558, J152HM0559, J152HM0560, J152HM0561, J152HM0562, J152HM0563, J152HM0564, J152HM0565, J152HM0566, J152HM0567, J152HM0568, J152HM0569, J171HE0692, J171HE0693, J171HE0694, J171HE0695, J171HE0696, J171HE0697, J171HE0698, J171HE0699, J171HE0700, J171HE0701, J171HE0702, J171HE0703, J171HE0704, J171HE0705, J171HE0706, J171HE0707, J171HE0708, J171HE0709, J171HE0710, J171HE0711, J308HE1943, J308HE1944, J308HE1945, J308HE1946, J308HE1947, J308HE1948, J308HE1949, J308HE1950, J308HE1951, J308HE1952, J308HE1953, J308HE1954, J308HE1955, J308HE1956, J308HE1957, K052HE0626, K052HE0627, K052HE0628, K052HE0629, K052HE0630, K052HE0631, K052HE0632, K052HE0633, K052HE0634, K052HE0635, K052HE0636, K052HE0637, K052HE0638, K052HE0639, K052HE0640, K052HE0641, K052HE0642, K052HE0643, K052HE0644, K052HE0645, K052HE0646, K052HE0647, K180HE2509, K180HE2510, K180HE2511, K180HE2512, K180HE2513, K180HE2514, K180HE2515, K180HE2516, K180HE2517, K180HE2518, K180HE2519, K180HE2520, K180HE2521, K180HE2522, K180HE2523, K180HE2524, K180HE2525, K180HE2526, K180HE2527, K180HE2528, J249H31428, J249HE1429, J341HE2538, J341HE2539, J341HE2540, J341HE2541, J341HE2542, J341HE2543, J341HE2544, J341HE2545, J341HE2546, J341HE2547, J341HE2548, J341HE2549, J341HE2550, J341HE2551, J341HE2552, K112HE1485, K112HE1486, K112HE1487, K112HE1488, K112HE1489, K112HE1490, K112HE1491, K112HE1492, K112HE1493, K112HE1494, K112HE1495, K112HE1496, K112HE1497, K112HE1498, K112HE1499, K112HE1500, K112HE1501, K112HE1502, K112HE1503, K112HE1504, K112HE1505, K112HE1506, K112HE1507, K112HE1508, K112HE1509, K112HE1510, K112HE1511, K112HE1512, K112HE1513, K112HE1514, J332HE2294, J332HE2295, J332HE2296, J332HE2297, J332HE2298, J332HE2299, J332HE2300, J332HE2301, J332HE2302, J332HE2303, J332HE2304, J332HE2305, J332HE2306, J332HE2307, J332HE2308, J332HE2309, J332HE2310, J332HE2311, J332HE2312, J332HE2313, J332HE2314, J332HE2315, J332HE2316, J332HE2317, J332HE2318, J332HE2319, J332HE2320, J332HE2321, J332HE2322, J332HE2323, J332HE2324, J332HE2325, J332HE2326, J332HE2327, J332HE2328, J332HE2329, J332HE2330, J332HE2331, J332HE2332, J332HE2333, J332HE2334, J332HE2335, J333HE2336, J333HE2337, J333HE2338, J333HE2339, J333HE2340, J333HE2341, J333HE2342, J333HE2343, J333HE2344, J333HE2345, J333HE2346, J333HE2347, J333HE2348, J333HE2349, J333HE2350, J333HE2351, J333HE2352, J333HE2353, J333HE2354, J333HE2355, J333HE2356, J333HE2357, J333HE2358, J333HE2359, J333HE2360, J333HE2361, J333HE2362, J333HE2363, J333HE2364, J333HE2365, J333HE2366, J333HE2367, J333HE2368, J333HE2369, J333HE2370, J333HE2371, J333HE2372, J333HE2373, J333HE2374, J333HE2375, J333HE2376, J333HE2377, J334HE2378, J334HE2379, J334HE2380, J334HE2381, J334HE2382, J334HE2383, J334HE2384, J334HE2385, J334HE2386, J334HE2387, J334HE2388, J334HE2389, J334HE2390, J334HE2391, J334HE2392, J334HE2393, J282HE1687, J249H31427, J269HE1486, J269HE1487, J269HE1488, J269HE1489, J269HE1490, J269HE1491, J269HE1492, J269HE1493, J269HE1494, J269HE1495, J269HE1496, J269HE1497, J269HE1498, J269HE1499, J269HE1500, J269HE1501, J269HE1502, J269HE1503, J269HE1504, J269HE1505, J269HE1506, J269HE1507, J269HE1508, J269HE1509, J269HE1510, J269HE1511, J269HE1512, J269HE1513, J269HE1514, J269HE1515, J269HE1516, J269HE1517, J269HE1518, J269HE1519, J269HE1520, J269HE1521, J270HE1522, J270HE1523, J270HE1524, J270HE1525, J270HE1526, J270HE1527, J270HE1528, J270HE1529, J270HE1530, J270HE1531, J270HE1532, J270HE1533, J270HE1534, J270HE1535, J270HE1536, J270HE1537, J270HE1538, J270HE1539, J270HE1540, J270HE1541, J270HE1542, J270HE1543, J270HE1544, J270HE1545, J270HE1546, J270HE1547, J270HE1548, J270HE1549, J270HE1550, J270HE1551, J270HE1552, J270HE1553, J270HE1554, J270HE1555, J270HE1556, J270HE1557, J270HE1558, J270HE1559, J270HE1560, J270HE1561, J270HE1562, J270HE1563, J270HE1564, J270HE1565, J270HE1566, J270HE1567, J270HE1568, J270HE1569, J270HE1570, J270HE1571, J270HE1572, J270HE1573, J270HE1574, J270HE1575, J270HE1576, J270HE1577, J270HE1578, J270HE1579, J270HE1580, J270HE1581, J271HE1582, J271HE1583, J271HE1584, J271HE1585, J271HE1586, J271HE1587, J271HE1588, J271HE1589, J271HE1590, J271HE1591, J271HE1592, J271HE1593, J271HE1594, J271HE1595, J271HE1596, J271HE1597, J271HE1598, J271HE1599, J271HE1600, J271HE1601, J271HE1602, J271HE1603, J271HE1604, J271HE1605, J271HE1606, J271HE1607, J271HE1608, J271HE1609, J271HE1610, J271HE1611, J271HE1612, J271HE1613, J271HE1614, J271HE1615, J271HE1616, J271HE1617, J271HE1618, J271HE1619, J271HE1620, J271HE1621, J271HE1622, J271HE1623, J271HE1624, J271HE1625, J271HE1626, J271HE1627, J271HE1628, J271HE1629, J271HE1630, J271HE1631, J271HE1632, J271HE1633, J271HE1634, J271HE1635, J271HE1636, J271HE1637, J271HE1638, J271HE1639, J271HE1640, J271HE1641, J272HE1642, J272HE1643, J272HE1644, J272HE1645, J272HE1646, J272HE1647, J272HE1648, J272HE1649, J272HE1650, J272HE1651, J272HE1652, J272HE1653, J272HE1654, J272HE1655, J272HE1656, J272HE1657, J272HE1658, J272HE1659, J272HE1660, J272HE1661, J272HE1662, J272HE1663, J272HE1664, J272HE1665, J272HE1666, J272HE1667, J272HE1668, J272HE1669, J272HE1670, J272HE1671, J272HE1672, J272HE1673, J272HE1674, J272HE1675, J272HE1676, J272HE1677, J272HE1678, J272HE1679, J272HE1680, J272HE1681, J272HE1682, J272HE1683, J272HE1684, J272HE1685, K007H30043, K007HE0041, K007HE0042, K119HE1667, K189HE2671, K189HE2672, K189HE2673, K189HE2674, K189HE2675, K189HE2676, K189HE2677, K189HE2678, K189HE2679, K189HE2680, K189HE2681, K189HE2682, K189HE2683, K190HE2684, K190HE2685, K190HE2686, K194HE2687, K194HE2688, K194HE2689, K194HE2690, K194HE2691, K195HE2692, K195HE2693, K195HE2694, K195HE2695, K195HE2696, K195HE2697, K195HE2698, J282HE1686, J187HE0740, J187HE0741, J187HE0742, J187HE0743, J187HE0744, J187HE0745, J187HE0746, J187HE0747, J187HE0748, J187HE0749, J187HE0750, J187HE0751, J187HE0752, J187HE0753, J187HE0754, J187HE0755, J187HE0756, J187HE0757, J187HE0758, J187HE0759, J187HE0760, J187HE0761, J187HE0762, J187HE0763, J187HE0764, J187HE0765, J187HE0766, J187HE0767, J187HE0768, J187HE0769, K164HE2219, K164HE2220, J321HE2157, J321HE2158, J321HE2159, J321HE2160, J321HE2161, J321HE2162, J321HE2163, J321HE2164, J321HE2165, J321HE2166, J321HE2167, J321HE2168, J321HE2169, J321HE2170, J321HE2171, J321HE2172, J321HE2173, J321HE2174, J321HE2175, J321HE2176, J321HE2177, J321HE2178, J321HE2179, J321HE2180, J321HE2181, J321HE2182, J321HE2183, J321HE2184, J321HE2185, J321HE2186, J321HE2187, J321HE2188, UNKNOWN, J291HE1792, J291HE1793, J291HE1794, J291HE1795, J291HE1796, J291HE1797, J291HE1798, J291HE1799, J291HE1800, J291HE1801, K008HE0044, K008HE0045, K008HE0046, K008HE0047, K008HE0048, K008HE0049, K008HE0050, K008HE0051, K008HE0052, K008HE0053, K008HE0054, K008HE0055, K008HE0056, K008HE0057, K008HE0058, K008HE0059, K008HE0060, K008HE0061, K008HE0062, K008HE0063, K008HE0064, K008HE0065, K008HE0066, K008HE0067, K008HE0068, K008HE0069, K008HE0070, K009HE0071, K009HE0072, K009HE0073, K009HE0074, K009HE0075, K009HE0076, K009HE0077, K139HE1880, K139HE1881, K139HE1882, K139HE1883, K139HE1884, K139HE1885, K139HE1886, K139HE1887, K139HE1888, K139HE1889, K139HE1890, K139HE1891, K139HE1892, K139HE1893, K139HE1894, K139HE1895, K139HE1896, K139HE1897, K139HE1898, K139HE1899, K139HE1900, K139HE1901, K139HE1902, K139HE1903, K139HE1904, K139HE1905, K139HE1906, K139HE1907, K139HE1908, K139HE1909, K139HE1910, K139HE1911, K139HE1912, K139HE1913, K139HE1914, K139HE1915, K139HE1916, K139HE1917, K139HE1918, K139HE1919, K139HE1920, K139HE1921, K139HE1922, K139HE1923.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Argentina, Bahrain, Bhutan, Brazil, Bulgaria, Chili, China, Columbia, Costa Rica, Ecuador, Egypt, Eritrea, France, Hong Kong, India, Indonesia, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Syria, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Arab Emirates, United States, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    Hill-Rom 405 Bed, P1440B, (electric) Hill Rom Batesville, IN. || Intended for low to moderate acuity patients in the low end acute care area of the hospital.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • 제조사 모회사 (2017)
  • Source
    USFDA