Rappel de Device Recall HillRom Affinity Four Birthing Bed

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Hill-Rom, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53987
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0548-2010
  • Date de mise en oeuvre de l'événement
    2009-11-16
  • Date de publication de l'événement
    2009-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Table, obstetrical, ac-powered (and accessories) - Product Code HDD
  • Cause
    The brakes may not hold or lock.
  • Action
    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

  • Modèle / numéro de série
    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, 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Manufacturer

  • Adresse du fabricant
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • Société-mère du fabricant (2017)
  • Source
    USFDA