Events

Device Recall HillRom Affinity Four Birthing 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
    53987
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0548-2010
  • 사례 시작날짜
    2009-11-16
  • 사례 출판 날짜
    2009-12-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86989
  • 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
    Table, obstetrical, ac-powered (and accessories) - Product Code HDD
  • 원인
    The brakes may not hold or lock.
  • 조치
    Hill-Rom issued an "Urgent Safety Notice" notification dated November 16, 2009 to customers. The letter advised users of the problem and asking them to locate the beds and to remove them from use until corrected if possible and, if not possible to inspect them for the problem and remove them from use if it is present. The firm will visit each account to make corrections. For further information, contact Hill-Rom Technical Support at 1-800-445-3720.

Device

Device Recall HillRom Affinity Four Birthing Bed
  • 모델명 / 제조번호(시리얼번호)
    All beds distributed between 11/27/06 and 6/18/08. Serial Numbers: H299AA4675, H299AA4676, H299AA4679, H299AA4681, H331AA4786, H331AA4787, H331AA4788, H332AA4789, H332AA4790, H332AA4791, H332AA4792, H332AA4793, H332AA4794, H332AA4795, H333AA4796, H333AA4797, H333AA4798, H333AA4799, H333AA4800, H333AA4802, H334AA4803, H334AA4804, H334AA4805, H334AA4807, H334AA4808, H334AA4809, H334AA4810, H335AA4801, H335AA4811, H335AA4812, H335AA4813, H335AA4814, H338AA4822, H338AA4823, H338AA4824, H338AA4825, H338AA4826, H338AA4829, H339AA4831, H339AA4832, H339AA4833, H339AA4835, H339AA4836, H339AA4837, H339AA4838, H339AA4839, H339AA4840, H340AA4841, H340AA4842, H340AA4843, H340AA4844, H340AA4845, H340AA4846, H340AA4849, H340AA4850, H340AA4851, H340AA4852, H341AA4853, H341AA4854, H341AA4855, H341AA4856, H341AA4857, H341AA4860, H341AA4861, H342AA4862, H342AA4863, H342AA4864, H342AA4865, H342AA4868, H342AA4870, H345AA4874, H345AA4875, H345AA4876, H345AA4877, H345AA4879, H345AA4880, H345AA4881, H346AA4883, H346AA4884, H346AA4887, H346AA4889, H347AA4891, H347AA4892, H347AA4893, H347AA4895, H347AA4897, H347AA4899, H347AA4901, H348AA4903, H348AA4905, H348AA4907, H348AA4908, H348AA4910, H348AA4912, H348AA4913, H349AA4917, H349AA4919, H352AA4931, H352AA4933, H353AA4934, H354AA4950, H354AA4951, H355AA4955, H355AA4959, H356AA4964, H356AA4968, I002AA4976, I002AA4980, I002AA4981, I003AA4985, I003AA4987, I003AA4988, I004AA4995, I004AA4997, I004AA4998, I004AA5000, I005AA5006, I005AA5009, I008AA5016, I008AA5017, I008AA5018, I008AA5024, I009AA5026, I009AA5027, I009AA5028, I009AA5029, I009AA5031, I010AA5048, I010AA5049, I011AA5050, I011AA5051, I012AA5070, I015AA5071, I015AA5072, I015AA5073, I015AA5074, I015AA5075, I015AA5076, I015AA5077, I015AA5078, I015AA5080, I016AA5081, I016AA5082, I016AA5084, I016AA5085, I026AA5171, I026AA5172, I029AA5173, I029AA5174, I029AA5175, I029AA5176, I029AA5177, I029AA5178, I029AA5179, I029AA5180, I029AA5181, I029AA5182, I033AA5217, I033AA5218, I033AA5219, I033AA5220, I033AA5221, I033AA5222, I036AA5223, I036AA5225, I036AA5226, I036AA5227, I036AA5228, I036AA5229, I036AA5230, I043AA5267, I043AA5268, I043AA5269, I043AA5270, I043AA5271, I043AA5272, I043AA5273, I044AA5274, I046AA5282, I046AA5283, I046AA5290, I046AA5291, I047AA5292, I047AA5293, I047AA5301, I050AA5311, I050AA5312, I050AA5313, I050AA5314, I051AA5319, I051AA5320, I051AA5321, I051AA5322, I051AA5324, I052AA5325, I052AA5327, I052AA5328, I052AA5329, I052AA5330, I052AA5331, I052AA5332, I052AA5333, I052AA5334, I053AA5335, I053AA5336, I053AA5338, I053AA5339, I053AA5341, I053AA5342, I053AA5343, I053AA5344, I054AA5345, I054AA5346, I054AA5347, I054AA5348, I054AA5349, I054AA5350, I057AA5361, I058AA5368, I058AA5369, I058AA5370, I058AA5371, I058AA5372, I058AA5374, I059AA5375, I059AA5376, I059AA5377, I059AA5378, I059AA5379, I059AA5380, I059AA5382, I059AA5383, I059AA5384, I059AA5385, I060AA5386, I060AA5387, I060AA5388, I060AA5388, I060AA5389, I060AA5390, I060AA5395, I061AA5397, I061AA5402, I061AA5403, I061AA5404, I064AA5405, I064AA5406, I064AA5407, I064AA5408, I064AA5409, I064AA5410, I064AA5412, I064AA5413, I064AA5415, I064AA5416, I064AA5417, I065AA5419, I065AA5421, I065AA5422, I065AA5423, I065AA5424, I065AA5425, I065AA5426, I065AA5428, I065AA5429, I065AA5430, I066AA5431, I066AA5433, I066AA5434, I066AA5436, I066AA5437, I066AA5438, I066AA5439, I066AA5440, I066AA5441, I066AA5442, I067AA5444, I067AA5445, I067AA5446, I067AA5448, I067AA5449, I067AA5451, I067AA5452, I067AA5453, I067AA5454, I067AA5455, I067AA5457, I068AA5458, I068AA5459, I068AA5460, I068AA5461, I068AA5462, I068AA5467, I071AA5473, I071AA5476, I071AA5477, I071AA5478, I071AA5479, I071AA5480, I071AA5483, I071AA5484, I071AA5486, I072AA5487, I072AA5488, I072AA5489, I072AA5492, I072AA5494, I072AA5495, I072AA5496, I072AA5501, I073AA5502, I073AA5503, I073AA5505, I073AA5506, I073AA5507, I073AA5508, I073AA5509, I073AA5511, I073AA5512, I073AA5513, I073AA5514, I073AA5515, I073AA5517, I074AA5518, I074AA5519, I074AA5524, I074AA5525, I074AA5527, I074AA5528, I074AA5529, I074AA5530, I074AA5531, I074AA5532, I075AA5535, I075AA5536, I075AA5537, I075AA5538, I075AA5539, I075AA5540, I075AA5541, I075AA5543, I075AA5544, I076AA5547, I076AA5549, I078AA5550, I078AA5552, I078AA5553, I078AA5555, I078AA5556, I078AA5557, I078AA5558, I078AA5559, I078AA5560, I078AA5561, I078AA5562, I079AA5563, I079AA5564, I079AA5565, I079AA5566, I079AA5567, I079AA5568, I079AA5569, I079AA5570, I079AA5571, I079AA5572, I079AA5573, I079AA5574, I079AA5575, I080AA5576, I080AA5577, I080AA5578, I080AA5579, I080AA5580, I080AA5582, I080AA5584, I080AA5585, I080AA5586, I080AA5587, I080AA5590, I080AA5591, I081AA5592, I081AA5595, I081AA5596, I081AA5597, I081AA5598, I081AA5599, I081AA5602, I081AA5604, I081AA5605, I081AA5607, I081AA5609, I081AA5610, I082AA5612, I082AA5613, I082AA5615, I082AA5616, I082AA5618, I082AA5621, I082AA5623, I082AA5624, I082AA5625, I085AA5626, I085AA5627, I085AA5628, I085AA5629, I085AA5630, I085AA5631, I085AA5632, I085AA5635, I085AA5636, I085AA5637, I085AA5639, I086AA5641, I087AA5642, I087AA5643, I087AA5644, I087AA5647, I087AA5649, I087AA5650, I088AA5655, I088AA5656, I088AA5658, I088AA5660, I088AA5661, I088AA5662, I088AA5663, I088AA5664, I088AA5666, I089AA5669, I089AA5676, I089AA5679, I092AA5680, I092AA5681, I092AA5683, I093AA5684, I093AA5685, I093AA5686, I093AA5687, I093AA5688, I093AA5690, I093AA5691, I093AA5693, I093AA5695, I094AA5698, I094AA5700, I094AA5703, I094AA5704, I094AA5708, I095AA5712, I095AA5713, I095AA5716, I095AA5719, I095AA5721, I099AA5726, I099AA5727, I099AA5728, I099AA5729, I099AA5730, I099AA5731, I099AA5732, I099AA5733, I099AA5735, I099AA5736, I099AA5737, I099AA5738, I099AA5739, I100AA5742, I100AA5744, I100AA5745, I100AA5746, I100AA5748, I100AA5749, I100AA5752, I100AA5753, I100AA5754, I100AA5755, I100AA5756, I101AA5757, I101AA5758, I101AA5759, I101AA5760, I101AA5763, I101AA5764, I101AA5765, I101AA5766, I101AA5767, I101AA5768, I101AA5769, I101AA5770, I102AA5773, I102AA5775, I102AA5777, I102AA5779, I102AA5785, I102AA5787, I103AA5788, I103AA5789, I103AA5791, I103AA5792, I103AA5793, I103AA5796, I103AA5800, I103AA5802, I106AA5804, I106AA5805, I106AA5806, I106AA5809, I106AA5811, I106AA5812, I106AA5813, I106AA5814, I106AA5815, I106AA5816, I106AA5817, I106AA5818, I107AA5819, I107AA5820, I107AA5821, I107AA5822, I107AA5823, I107AA5824, I107AA5825, I107AA5826, I107AA5827, I107AA5828, I107AA5829, I107AA5830, I107AA5831, I107AA5832, I107AA5833, I108AA5834, I108AA5835, I108AA5836, I108AA5837, I108AA5838, I108AA5839, I108AA5841, I108AA5842, I109AA5850, I109AA5856, I109AA5858, I110AA5863, I110AA5864, I110AA5866, I110AA5867, I110AA5868, I110AA5869, I110AA5870, I110AA5871, I110AA5873, I110AA5874, I110AA5875, I113AA5876, I113AA5877, I113AA5878, I113AA5879, I113AA5880, I113AA5881, I113AA5882, I113AA5884, I113AA5885, I113AA5886, I113AA5887, I113AA5889, I113AA5890, I113AA5891, I114AA5892, I114AA5893, I114AA5895, I114AA5896, I114AA5897, I114AA5898, I114AA5899, I115AA5909, I116AA5927, I116AA5929, I116AA5930, I116AA5931, I116AA5932, I116AA5933, I116AA5934, I116AA5935, I117AA5936, I117AA5937, I117AA5938, I117AA5940, I117AA5941, I117AA5942, I117AA5943, I117AA5945, I117AA5946, I117AA5947, I117AA5948, I120AA5952, I120AA5954, I120AA5956, I120AA5957, I120AA5959, I120AA5960, I120AA5961, I120AA5962, I120AA5963, I120AA5965, I121AA5967, I121AA5968, I121AA5969, I121AA5971, I121AA5972, I121AA5973, I121AA5974, I121AA5976, I121AA5980, I121AA5982, I122AA5986, I122AA5988, I122AA5990, I122AA5993, I122AA5994, I122AA5997, I123AA6000, I123AA6001, I123AA6003, I123AA6005, I123AA6007, I123AA6008, I123AA6009, I123AA6010, I123AA6011, I123AA6012, I123AA6013, I123AA6014, I123AA6015, I123AA6016, I124AA6017, I124AA6019, I124AA6021, I124AA6022, I124AA6024, I124AA6026, I124AA6028, I124AA6030, I124AA6031, I127AA6032, I127AA6033, I127AA6034, I127AA6035, I127AA6036, I127AA6037, I127AA6038, I127AA6041, I127AA6042, I127AA6045, I127AA6046, I127AA6047, I128AA6050, I128AA6051, I128AA6052, I128AA6053, I128AA6054, I128AA6055, I129AA6065.I129AA6067, I129AA6069, I129AA6070, I129AA6071, I129AA6072, I129AA6073, I129AA6075, I129AA6076, I129AA6077, I130AA6081, I130AA6085, I130AA6086, I130AA6091, I131AA6096, I131AA6103, I131AA6104, I131AA6106, I134AA6113, I134AA6114, I134AA6115, I134AA6119, I134AA6121, I134AA6122, I134AA6123, I134AA6124, I134AA6125, I134AA6129, I135AA6134, I135AA6137, I135AA6139, I135AA6140, I135AA6141, I135AA6142, I135AA6143, I135AA6144, I136AA6146, I136AA6147, I136AA6148, I136AA6149, I136AA6150, I136AA6151, I136AA6152, I136AA6153, I136AA6155, I136AA6157, I136AA6158, I137AA6165, I138AA6179, I138AA6190, I141AA6195, I141AA6197, I141AA6198, I141AA6199, I141AA6200, I141AA6201, I141AA6206, I142AA6213, I142AA6215, I142AA6216, I142AA6217, I142AA6218, I142AA6219, I142AA6220, I142AA6221, I143AA6223, I144AA6246, I144AA6247, I144AA6249, I144AA6250, I144AA6251, I144AA6252, I144AA6253, I145AA6264, I145AA6265, I145AA6266, I149AA6268, I149AA6269, I149AA6270, I149AA6271, I149AA6272, I149AA6273, I149AA6274, I149AA6276, I149AA6277, I150AA6279, I150AA6280, I150AA6281, I150AA6282, I150AA6283, I150AA6284, I150AA6285, I150AA6286, I150AA6287, I151AA6288, I151AA6289, I151AA6291, I151AA6292, I152AA6303, I152AA6304, I152AA6306, I152AA6307, I152AA6308, I152AA6309, I152AA6310, I155AA6311, I155AA6312, I155AA6316, I155AA6317, I156AA6320, I156AA6321, I156AA6322, I156AA6323, I156AA6324, I156AA6326, I156AA6327, I156AA6328, I157AA6329, I157AA6330, I157AA6331, I157AA6332, I157AA6333, I157AA6334, I157AA6335, I157AA6336, I157AA6337, I157AA6338, I158AA6339, I158AA6340, I158AA6341, I158AA6342, I158AA6343, I158AA6344, I158AA6345, I158AA6346, I158AA6347, I159AA6354, I159AA6357, I159AA6358, I162AA6359, I162AA6360, I162AA6361, I162AA6365, I162AA6367, I162AA6368, I162AA6369, I163AA6372, I163AA6373, I163AA6374, I163AA6375, I163AA6376, I163AA6377, I163AA6378, I163AA6379, I163AA6380, I163AA6381, I164AA6382, I164AA6383, I164AA6384, I164AA6385, I164AA6386, I165AA6393, I166AA6408, I166AA6409, I166AA6410, I166AA6411, I169AA6417, I169AA6420, I169AA6421, I169AA6422, I169AA6423, I170AA6424, I170AA6425, I170AA6426, I170AA6427, I170AA6428, I170AA6429, I170AA6430, I170AA6431, I170AA6432, I170AA6433, I171AA6434, I171AA6435, I171AA6436, I171AA6437, I171AA6438, I171AA6439, I171AA6440, I171AA6441, I171AA6442, I171AA6443, I172AA6444, I172AA6445, I172AA6446, I172AA6447, I172AA6448, I172AA6449, I172AA6450, I172AA6451, I172AA6452, I172AA6453, I173AA6454, I173AA6455, I173AA6456, I173AA6457, I173AA6459, I173AA6460, I173AA6463, I176AA6464, I176AA6465, I176AA6467, I176AA6468, I176AA6469, I176AA6470, I176AA6471, I176AA6472, I177AA6474, I177AA6477, I177AA6478, I177AA6482, I178AA6485, I178AA6486, I178AA6487, I178AA6488, I178AA6489, I178AA6491, I178AA6493, I179AA6494, I179AA6495, I179AA6498, I179AA6499, I179AA6500, I179AA6502, I180AA6508, I180AA6509, I180AA6510, I180AA6511, I180AA6512, I190AA6513, I190AA6514, I190AA6516, I190AA6518, I190AA6519, I190AA6520, I190AA6521, I190AA6522, I191AA6523, I191AA6524, I191AA6525, I191AA6526, I191AA6527, I191AA6528, 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  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libiya, Netherlands, Poland, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Syria, Thailand, Turkey and United Arab Emirates.
  • 제품 설명
    Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. || Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • 제조사 주소
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA