Events

HillRom 100 Low 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
    51389
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0338-2010
  • 사례 시작날짜
    2009-04-20
  • 사례 출판 날짜
    2009-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80169
  • 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 siderails may exhibit false latching, or unintentional lowering, or may become inoperable.
  • 조치
    Hill Rom notified consignees by recall letter dated 4/20/09 and advised them of the problem and requested them to locate the beds. Consignees with patients in need of siderails were directed to be moved to a different model bed with siderails and, if the patient did not need siderails; consignees were requested to remove the siderails, move the siderails to a stowed position, to tie the siderail to the bed frame or to tag the siderail as out of service. The letter stated the consignee would be contacted within 90 days by a firm representative to do a correction on all affected units.

Device

HillRom 100 Low Bed
  • 모델명 / 제조번호(시리얼번호)
    All units shipped prior to 3/6/09. 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K007AR5904, K007AR5905, K007AR5906, K007AR5908, K007AR5909, K007AR5910, K007AR5911, K007AR5914, K007AR5915, K008AR5917, K008AR5918, K008AR5919, K008AR5920, K008AR5921, K008AR5926, K008AR5928, K008AR5929, K008AR5930, K008AR5931, K008AR5932, K008AR5933, K008AR5934, K008AR5935, K008AR5936, K008AR5937, K008AR5938, K008AR5940, K008AR5942, K022AR5944, K022AR5945, K022AR5946, K022AR5947, K022AR5948, K022AR5949, K022AR5950, K022AR5951, K022AR5952, K022AR5953, K022AR5954, K022AR5955, K022AR5956, K022AR5957, K022AR5958, K022AR5959, K022AR5963, K022AR5964, K023AR5965, K023AR5966, K023AR5967, K023AR5968, K023AR5969, K023AR5970, K023AR5971, K023AR5972, K023AR5975, K023AR5976, K023AR5977, K023AR5978, K023AR5979, K023AR5981, K026AR5982, K026AR5983, K026AR5985, K026AR5986, K026AR5987, K026AR5988, K026AR5989, K026AR5990, K026AR5991, K026AR5992, K026AR5993, K027AR6002, K027AR6003, K027AR6008, K027AR6009, K027AR6010, K027AR6011, K027AR6012, K027AR6013, K027AR6014, K027AR6015, K027AR6016, K027AR6017, 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K049AR6123, K049AR6125, K049AR6128, K049AR6129, K049AR6131, K050AR6134, K050AR6136, K050AR6137, K050AR6138, K050AR6139, K050AR6140, K050AR6141, K050AR6142, K050AR6143, K050AR6144, K050AR6145, K050AR6146, K050AR6149, K051AR6150, K051AR6151, K051AR6152, K051AR6153, K051AR6154, K051AR6155, K051AR6158, K051AR6159, K051AR6160, K051AR6161, K054AR6162, K054AR6163, K054AR6164, K054AR6165, K054AR6166, K054AR6167, K054AR6168, K054AR6169, K054AR6170, K054AR6171, K054AR6172, K054AR6173, K054AR6174, K054AR6175, K054AR6176, K054AR6177, K054AR6178, K055AR6179, K055AR6180, K055AR6181, K055AR6182, K055AR6183, K055AR6184, K055AR6185, K055AR6186, K055AR6187, K055AR6192, K055AR6193, K056AR6204, K056AR6205, K056AR6206, K056AR6207, K057AR6216, K057AR6217, K057AR6220, K057AR6221, K057AR6222, K057AR6223, K057AR6224, K057AR6225, K057AR6226, K058AR6227, K058AR6228, K058AR6229, K058AR6230, K058AR6231, K058AR6232, K058AR6233, K058AR6234, K058AR6235, K058AR6236, K068AR6253, K068AR6256, K068AR6257, K071AR6299, K071AR6300, K071AR6301, K071AR6302, K072AR6309, K072AR6310, K072AR6313, K072AR6314, K072AR6315, K072AR6316, K072AR6317, K072AR6318, K072AR6319, K075AR6320, K075AR6321, K075AR6322, K075AR6323, K075AR6324, K075AR6325, K075AR6326, K075AR6327, K075AR6328, K075AR6329, K075AR6330, K075AR6331, K075AR6332, K075AR6333, K075AR6334, K075AR6335, K075AR6336, K075AR6337, K076AR6338, K076AR6355, K076AR6356, K076AR6367, K078AR6375, K078AR6376, K078AR6377, K078AR6378, K078AR6379, K078AR6380, K078AR6381, K078AR6382, K078AR6383, K078AR6384, K078AR6385, K079AR6386, K079AR6387, K079AR6388, K079AR6389, K079AR6390, K079AR6391, K079AR6392, K079AR6393, K079AR6394, K079AR6395, K079AR6396, K079AR6397, K079AR6398, K079AR6399, K079AR6400, K082AR6402, K082AR6403, K082AR6406, K082AR6407, K082AR6408, K082AR6409, K082AR6410, K082AR6411, K082AR6412, K082AR6413, K082AR6414, K082AR6415, K083AR6416, K083AR6417, K083AR6418, K083AR6419, K083AR6420, K083AR6421, K083AR6422, K083AR6423, K083AR6424, K084AR6439, K084AR6440, K084AR6441, K084AR6442, K084AR6443, K084AR6444, K084AR6446, K084AR6447, K085AR6448, K085AR6449, K085AR6450, K085AR6451, K085AR6452, K085AR6453, K085AR6454, K085AR6455, K085AR6456, K085AR6457, K085AR6458, K085AR6459, K085AR6460, K085AR6461, K085AR6462, K085AR6463, K085AR6464, K086AR6465, K086AR6466, K086AR6467, K086AR6468, K086AR6469, K086AR6470, K086AR6471, K086AR6472, K086AR6473, K086AR6474, K086AR6476, K096AR6481, K096AR6482, K096AR6484, K096AR6485, K096AR6486, K096AR6487, K096AR6488, K096AR6489, K096AR6490, K096AR6491, K096AR6492, K096AR6493, K096AR6494, K097AR6495, K097AR6496, K097AR6497, K097AR6498, K097AR6499, K097AR6500, K097AR6502, K097AR6503, K097AR6504, K097AR6505, K097AR6506, K097AR6507, K097AR6508, K097AR6509, K097AR6510, K098AR6511, K098AR6512, K098AR6513, K098AR6514, K098AR6515, K098AR6516, K098AR6517, K098AR6518, K098AR6519, K098AR6520, K098AR6527, K098AR6528, K098AR6529, K098AR6530, K098AR6531, K099AR6532, K099AR6533, K099AR6534, K099AR6535, K099AR6536, K099AR6537, K099AR6538, K099AR6539, K099AR6540, K099AR6541, K099AR6543, K099AR6544, K110AR6545, K110AR6546, K110AR6547, K110AR6548, K110AR6549, K110AR6550, K110AR6551, K110AR6552, K110AR6553, K110AR6554, K110AR6555, K110AR6556, K110AR6557, K110AR6561, K110AR6562, K110AR6563, K111AR6564, K111AR6565, K111AR6566, K111AR6567, K111AR6568, K111AR6569, K111AR6570, K111AR6571, K111AR6572, K111AR6573, K111AR6574, K111AR6575, K111AR6576, K111AR6577, K111AR6578, K111AR6579, K112AR6580, K112AR6581, K112AR6582, K112AR6583, K112AR6584, K112AR6585, K112AR6586, K112AR6587, K112AR6588, K112AR6589, K112AR6590, K112AR6591, K112AR6592, K112AR6593, K112AR6594, K112AR6595, K113AR6596, K113AR6597, K113AR6598, K113AR6599, K113AR6600, K113AR6601, K113AR6602, K113AR6603, K113AR6604, K113AR6605, K113AR6606, K113AR6607, K113AR6608, K113AR6609, K114AR6610, K114AR6611, K114AR6612, K114AR6613, K114AR6614, K114AR6615, K114AR6616, K114AR6617, K114AR6618, K114AR6619, K114AR6620, K114AR6621, K114AR6622, K114AR6623, K114AR6624, K114AR6625, K124AR6626, K124AR6627, K124AR6628, K124AR6629, K124AR6630, K124AR6631, K124AR6632, K124AR6633, K124AR6634, K124AR6635, K124AR6637, K124AR6638, K124AR6639, K124AR6640, K124AR6641, K124AR6642, K124AR6643, K125AR6644, K125AR6647, K125AR6648, K125AR6649, K125AR6650, K125AR6651, K125AR6652, K125AR6653, K125AR6654, K125AR6655, K125AR6656, K125AR6657, K125AR6658, K125AR6659, K125AR6660, K125AR6661, K125AR6662, K125AR6663, K126AR6664, K126AR6665, K126AR6666, K126AR6667, K126AR6668, K126AR6669, K126AR6670, K126AR6671, K126AR6672, K126AR6673, K126AR6674, K126AR6675, K126AR6676, K126AR6677, K126AR6678, K127AR6679, K127AR6680, K127AR6681, K127AR6682, K127AR6683, K127AR6684, K127AR6685, K127AR6686, K127AR6687, K127AR6688, K127AR6689, K127AR6690, K127AR6691, K127AR6692, K127AR6694, K127AR6695, K127AR6696, K131AR6697, K131AR6698, K131AR6699, K131AR6700, K131AR6701, K131AR6702, K131AR6703, K131AR6704, K131AR6705, K131AR6706, K131AR6708, K131AR6709, K131AR6710, K131AR6711, K131AR6712, K131AR6713, K131AR6714, K131AR6715, K131AR6716, K131AR6717, K131AR6718, K131AR6719, K131AR6720, K131AR6721, K131AR6722, K132AR6723, K132AR6724, K132AR6725, K132AR6726, K132AR6727, K132AR6728, K132AR6729, K132AR6730, K132AR6731, K132AR6732, K132AR6733, K132AR6734, K132AR6735, K132AR6736, K132AR6737, K132AR6738, K132AR6739, K132AR6740, K132AR6741, K132AR6742, K133AR6743, K133AR6744, K133AR6745, K133AR6746, K133AR6747, K133AR6748, K133AR6749, K133AR6750, K133AR6751, K133AR6752, K133AR6753, K133AR6754, K133AR6755, K133AR6756, K133AR6757, K133AR6758, K133AR6759, K133AR6760, K133AR6761, K134AR6763, K134AR6764, K134AR6765, K134AR6766, K134AR6767, K134AR6769, K134AR6771, K134AR6772, K135AR6778, K135AR6781, K135AR6782, K135AR6783, K135AR6786, K135AR6787, K135AR6790, K135AR6795, K135AR6796, K135AR6797, K138AR6798, K138AR6799, K138AR6800, K138AR6801, K138AR6802, K138AR6804, K138AR6805, K138AR6808, K138AR6809, K138AR6810, K138AR6811, K138AR6812, K138AR6813, K138AR6814, K138AR6815, K138AR6816, K138AR6817, K138AR6818, K139AR6819, K139AR6820, K139AR6821, K139AR6822, K139AR6823, K139AR6826, K139AR6827, K139AR6828, K139AR6829, K139AR6830, K139AR6831, K139AR6832, K139AR6833, K139AR6834, K139AR6835, K139AR6836, K139AR6837, K139AR6838, K139AR6839, K139AR6840, K139AR6841, K139AR6842, K139AR6843, K139AR6844, K139AR6845, K139AR6846, K140AR6847, K140AR6848, K140AR6849, K169AR6891, K169AR6892 and K169AR6893.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Canada, France, India, Singapore and Spain.
  • 제품 설명
    Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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