Rappel de HillRom Basic Care 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
    56018
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2170-2010
  • Date de mise en oeuvre de l'événement
    2009-09-16
  • Date de publication de l'événement
    2010-08-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-03-16
  • 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
    Manual Bed - Product Code FNJ
  • Cause
    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.
  • Action
    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

  • Modèle / numéro de série
    J343BE4440, J343BE4441, J343BE4442, J343BE4443, J343BE4444, J343BE4445, J343BE4446, J343BE4447, J343BE4448, J343BE4449, J343BE4450, J343BE4451, J343BE4452, J343BE4453, J343BE4454, J343BE4455, J343BE4456, J343BE4457, K092BM1266, K092BM1267, K092BM1268, K092BM1269, K092BM1270, K092BM1271, K092BM1272, K092BM1273, K092BM1299, K092BM1300, K092BM1301, K092BM1302, K092BM1303, K092BM1304, K092BM1305, K092BM1306, K092BM1307, K093BM1308, K093BM1309, K093BM1310, K093BM1311, K093BM1312, K093BM1313, K093BM1314, K093BM1315, K093BM1316, K093BM1317, K093BM1318, K093BM1319, K093BM1320, K093BM1321, J233BM2121, J233BM2122, J233BM2123, J233BM2124, J233BM2125, J233BM2126, J233BM2127, J233BM2128, J233BM2129, J233BM2130, J233BM2131, J233BM2132, J233BM2133, J233BM2134, J233BM2135, J233BM2136, J233BM2137, J233BM2138, J233BM2139, J233BM2140, J233BM2141, J233BM2142, J233BM2143, J233BM2144, J233BM2145, J233BM2146, J233BM2147, J233BM2148, J233BM2149, J233BM2150, J233BM2151, J233BM2152, J233BM2153, J233BM2154, J233BM2155, J233BM2156, J233BM2157, J233BM2158, J233BM2159, J233BM2160, J233BM2161, J233BM2162, J233BM2163, J233BM2164, J233BM2165, J233BM2166, J233BM2167, J233BM2168, J233BM2169, J233BM2170, J233BM2171, J233BM2172, J233BM2173, J233BM2174, J233BM2175, J233BM2176, J233BM2177, J233BM2178, J233BM2179, J233BM2180, J233BM2181, J233BM2182, J233BM2183, J233BM2184, J233BM2185, J233BM2186, J233BM2187, J233BM2188, J233BM2189, J233BM2190, J233BM2191, J233BM2192, J233BM2193, J233BM2194, J233BM2195, J233BM2196, J233BM2197, J233BM2198, J233BM2199, J233BM2200, J233BM2201, J233BM2202, J233BM2203, J233BM2204, J233BM2205, J233BM2206, J233BM2207, J233BM2208, J233BM2209, J233BM2210, J236BM2211, J236BM2212, J236BM2213, J236BM2214, J236BM2215, J236BM2216, J236BM2217, J236BM2218, J236BM2219, J236BM2220, J236BM2221, J236BM2222, J236BM2223, J236BM2224, J236BM2225, J236BM2226, J236BM2227, J236BM2228, J236BM2229, J236BM2230, J236BM2231, J236BM2232, J236BM2233, J236BM2234, J236BM2235, J236BM2236, J236BM2237, J236BM2238, J236BM2239, J236BM2240, J236BM2241, J236BM2242, J236BM2243, J236BM2244, J236BM2245, J236BM2246, J236BM2247, J236BM2248, J236BM2249, J236BM2250, J236BM2251, J236BM2252, J236BM2253, J236BM2254, J236BM2255, J237BM2256, J237BM2257, J237BM2258, J237BM2259, J237BM2260, J237BM2261, J237BM2262, J237BM2263, J237BM2264, J237BM2265, J237BM2266, J237BM2267, J237BM2268, J237BM2269, J237BM2270, J237BM2271, J237BM2272, J237BM2273, J237BM2274, J237BM2275, J237BM2276, J237BM2277, J237BM2278, J237BM2279, J237BM2280, J237BM2281, J237BM2282, J237BM2283, J237BM2284, J237BM2285, J237BM2286, J237BM2287, J237BM2288, J237BM2289, J237BM2290, J243BM2507, J243BM2508, J243BM2509, J243BM2510, J243BM2511, J243BM2512, J343BM4436, J343BM4437, J343BM4438, J343BM4439, K151BM2179, K151BM2180, K151BM2181, K151BM2182, K151BM2183, K151BM2184, K151BM2185, K154BM2536, K154BM2537, K154BM2538, J301BM3948, J301BM3949, J301BM3950, J301BM3951, J301BM3952, K071BM1274, K071BM1275, K071BM1276, K071BM1277, K071BM1278, K071BM1279, K071BM1280, K071BM1281, K071BM1282, K071BM1283, K071BM1284, K071BM1285, K071BM1286, K071BM1287, K071BM1288, K071BM1289, K071BM1290, K071BM1291, K071BM1292, K071BM1293, K072BM1294, K072BM1295, K072BM1296, K072BM1297, K072BM1298, J324BM4162, J324BM4163, J324BM4164, J324BM4165, J324BM4166, J324BM4167, J324BM4168, J324BM4169, J324BM4170, J324BM4171, J324BM4172, J324BM4173, J324BM4174, J324BM4175, J324BM4176, J324BM4177, J324BM4178, J324BM4179, J324BM4180, J324BM4181, J324BM4182, J324BM4183, J324BM4184, J324BM4185, J324BM4186, J324BM4187, J324BM4188, J324BM4189, J324BM4190, J324BM4191, J324BM4192, J324BM4193, J324BM4194, J324BM4195, J324BM4196, J324BM4197, J324BM4198, J325BM4199, J325BM4200, J325BM4201, J325BM4202, J325BM4203, J325BM4204, J325BM4205, J325BM4206, J325BM4207, J325BM4208, J325BM4209, J325BM4210, J325BM4211, J325BM4212, J325BM4213, J325BM4214, J274BM3372, J274BM3373, J274BM3374, J274BM3375, J274BM3376, J274BM3377, J274BM3378, J274BM3379, J274BM3380, J274BM3381, J274BM3382, J274BM3383, J274BM3384, J274BM3385, J274BM3386, J274BM3387, J274BM3388, J274BM3389, J274BM3390, J274BM3391, J274BM3392, J274BM3393, J274BM3394, J274BM3395, J274BM3396, J274BM3397, J274BM3398, J274BM3399, J274BM3400, J274BM3401, J274BM3402, J274BM3403, J274BM3404, J255BM2729, J255BM2730, J255BM2731, J255BM2732, J255BM2733, J255BM2734, J255BM2735, J255BM2736, J255BM2737, J255BM2738, J255BM2739, J255BM2740, J255BM2741, J255BM2742, J255BM2743, J255BM2744, J255BM2745, J255BM2746, J255BM2747, J255BM2748, J255BM2749, J255BM2750, J255BM2751, J255BM2752, J255BM2753, J255BM2754, J255BM2755, J255BM2756, J255BM2757, J255BM2758, J255BM2759, J255BM2760, J255BM2761, J255BM2762, J255BM2763, J255BM2764, J255BM2765, J255BM2766, J255BM2767, J255BM2768, J255BM2769, J255BM2770, J255BM2771, J255BM2772, J292BM3721, J292BM3722, J292BM3723, J292BM3724, J292BM3725, J292BM3726, J292BM3727, J292BM3728, J292BM3729, J292BM3730, J292BM3731, J292BM3732, J292BM3733, J292BM3734, J292BM3735, J292BM3736, J292BM3737, J292BM3738, J292BM3739, J292BM3740, J292BM3741, J292BM3742, J292BM3743, J292BM3744, J292BM3745, J292BM3746, J292BM3747, J292BM3748, J292BM3749, J292BM3750, J292BM3751, J292BM3752, J292BM3753, J292BM3754, J292BM3755, J292BM3756, J300BM3907, J300BM3908, J300BM3909, J300BM3910, J300BM3911, J300BM3912, J300BM3913, J300BM3914, J300BM3915, J300BM3916, J300BM3917, J300BM3918, J300BM3919, J300BM3920, J300BM3921, J300BM3922, J300BM3923, J300BM3924, J300BM3925, J300BM3926, J300BM3927, J300BM3928, J301BM3929, J301BM3930, J301BM3931, J301BM3932, J301BM3933, J301BM3934, J301BM3935, J301BM3936, J301BM3937, J301BM3938, J301BM3939, J301BM3940, J301BM3941, J301BM3942, J301BM3943, J301BM3944, J301BM3945, J301BM3946, J301BM3947, J301BM3953, J301BM3954, J301BM3955, J301BM3956, J301BM3957, J301BM3958, J301BM3959, J301BM3960, J301BM3961, J301BM3962, J301BM3963, J301BM3964, J301BM3965, J301BM3966, J301BM3967, J301BM3968, J301BM3969, J301BM3970, J322BM4105, J322BM4106, J322BM4107, J322BM4108, J322BM4109, K040BM0535, K040BM0536, K040BM0537, K040BM0538, K040BM0539, K041BM0540, K041BM0541, K041BM0542, K041BM0543, K041BM0544, K041BM0545, K041BM0546, K041BM0547, K041BM0548, K041BM0549, K041BM0550, K041BM0551, K041BM0552, K041BM0553, K041BM0554, K041BM0555, K041BM0556, K041BM0557, K041BM0558, K041BM0559, K041BM0560, K041BM0561, K041BM0562, K041BM0563, K041BM0564, K041BM0565, K041BM0566, K041BM0567, K041BM0568, K041BM0569, K041BM0570, K041BM0571, K041BM0572, K041BM0573, K041BM0574, K041BM0575, K041BM0576, K041BM0577, K041BM0578, K041BM0579, K041BM0580, K041BM0581, K041BM0582, K041BM0583, K041BM0584, K041BM0585, K041BM0586, K041BM0587, K041BM0588, K041BM0589, K042BM0590, K042BM0591, K042BM0592, K042BM0593, K042BM0594, K042BM0595, K042BM0596, K042BM0597, K042BM0598, K042BM0599, K042BM0600, K042BM0601, K042BM0602, K042BM0603, K042BM0604, K042BM0605, K042BM0606, K042BM0607, K042BM0608, K042BM0609, K042BM0610, K042BM0611, K042BM0612, K042BM0613, K042BM0614, K042BM0615, K042BM0616, K042BM0617, K042BM0618, K042BM0619, K042BM0620, K042BM0621, K042BM0622, K042BM0623, K042BM0624, K042BM0625, K042BM0626, K042BM0627, K042BM0628, K042BM0629, K042BM0630, K042BM0631, K042BM0632, K042BM0633, K042BM0634, K042BM0635, K042BM0636, K042BM0637, K042BM0638, K042BM0639, K043BM0640, K043BM0641, K043BM0642, K043BM0643, K043BM0644, K043BM0645, K043BM0646, K043BM0647, K043BM0648, K043BM0649, K043BM0650, K043BM0651, K043BM0652, K043BM0653, K043BM0654, K043BM0655, K043BM0656, K043BM0657, K043BM0658, K043BM0659, K043BM0660, K043BM0661, K043BM0662, K043BM0663, K043BM0664, K043BM0665, K043BM0666, K043BM0667, K043BM0668, K043BM0669, K043BM0670, K043BM0671, K043BM0672, K043BM0673, K043BM0674, K043BM0675, K043BM0676, K043BM0677, K043BM0678, K043BM0679, K043BM0680, K043BM0681, K043BM0682, K043BM0683, K043BM0684, K043BM0685, K043BM0686, K043BM0687, K043BM0688, K043BM0689, K044BM0690, K044BM0691, K044BM0692, K044BM0693, K044BM0694, K044BM0695, K044BM0696, K044BM0697, K044BM0698, K044BM0699, K044BM0700, K044BM0701, K044BM0702, K044BM0703, K044BM0704, K044BM0705, K044BM0706, K044BM0707, K044BM0708, K044BM0709, K044BM0710, K044BM0711, K044BM0712, K044BM0713, K044BM0714, K044BM0715, K044BM0716, K044BM0717, K044BM0718, K044BM0719, K044BM0720, K044BM0721, K044BM0722, K044BM0723, K044BM0724, K044BM0725, K044BM0726, K044BM0727, K044BM0728, K044BM0729, K044BM0730, K044BM0731, K044BM0732, K044BM0733, K044BM0734, K044BM0735, K044BM0736, K044BM0737, K044BM0738, K044BM0739, K045BM0740, K045BM0741, K045BM0742, K045BM0743, K045BM0744, K009BM0091, J355BM4754, J355BM4755, J355BM4756, J355BM4757, J355BM4758, J355BM4759, J355BM4760, J355BM4761, J355BM4762, J355BM4763, J355BM4764, J355BM4765, J355BM4766, J355BM4767, J355BM4768, J355BM4769, J355BM4770, J355BM4771, J355BM4772, J355BM4773, J355BM4774, J355BM4775, J355BM4776, J355BM4777, J355BM4778, J355BM4779, J355BM4780, J355BM4781, J355BM4782, J355BM4783, J355BM4784, J355BM4785, J355BM4786, J355BM4787, J355BM4788, J355BM4789, K009BM0092, K009BM0093, K009BM0094, K009BM0095, K009BM0096, K009BM0097, K009BM0098, K009BM0099, K009BM0100, K009BM0101, K009BM0102, K009BM0103, K009BM0104, K009BM0105, K009BM0106, K009BM0107, K009BM0108, K009BM0109, K009BM0110, K009BM0111, K009BM0112, K009BM0113, K009BM0114, K009BM0115, K009BM0116, K009BM0117, K009BM0118, K009BM0119, K009BM0120, K009BM0121, K010BM0122, K010BM0123, K010BM0124, K010BM0125, K010BM0126, K010BM0127, K010BM0128, K010BM0129, K010BM0130, K010BM0131, K010BM0132, K010BM0133, K010BM0134, K010BM0135, K010BM0136, K010BM0137, K010BM0138, K010BM0139, K010BM0140, K010BM0141, K010BM0142, K010BM0143, K010BM0144, K010BM0145, K010BM0146, K010BM0147, K010BM0148, K010BM0149, K010BM0150, K010BM0151, K010BM0152, K010BM0153, K010BM0154, K010BM0155, K010BM0156, K010BM0157, K010BM0158, K010BM0159, K010BM0160, K010BM0161, K010BM0162, K010BM0163, K010BM0164, K010BM0165, K010BM0166, K010BM0167, K010BM0168, K010BM0169, K010BM0170, K010BM0171, K011BM0172, K011BM0173, K011BM0174, K011BM0175, K011BM0176, K011BM0177, K011BM0178, K011BM0179, K011BM0180, K011BM0181, K011BM0182, K011BM0183, K011BM0184, K011BM0185, K011BM0186, K011BM0187, K011BM0188, K011BM0189, K011BM0190, K011BM0191, K011BM0192, K011BM0193, K011BM0194, K011BM0195, K011BM0196, K011BM0197, K011BM0198, K011BM0199, K011BM0200, K011BM0201, K011BM0202, K011BM0203, K011BM0204, K011BM0205, K011BM0206, K011BM0207, K011BM0208, K011BM0209, K011BM0210, K011BM0211, K011BM0212, K011BM0213, K011BM0214, K011BM0215, K011BM0216, K011BM0217, K011BM0218, K011BM0219, K011BM0220, K011BM0221, K012BM0222, K012BM0223, K012BM0224, K012BM0225, K012BM0226, K012BM0227, K012BM0228, K012BM0229, K012BM0230, K012BM0231, K012BM0232, K012BM0233, K012BM0234, K012BM0235, K012BM0236, K012BM0237, K012BM0238, K012BM0239, K012BM0240, K012BM0241, K012BM0242, K012BM0243, K012BM0244, K012BM0245, K012BM0246, K012BM0247, K012BM0248, K012BM0249, K012BM0250, K012BM0251, K012BM0252, K012BM0253, K012BM0254, K012BM0255, K012BM0256, K012BM0257, K012BM0258, K012BM0259, K012BM0260, K012BM0261, K012BM0262, K012BM0263, K012BM0264, K012BM0265, K012BM0266, K012BM0267, K012BM0268, K012BM0269, K012BM0270, K012BM0271, K013BM0272, K013BM0273, K013BM0274, K013BM0275, K013BM0276, K013BM0277, K013BM0278, K013BM0279, K013BM0280, K013BM0281, K013BM0282, K013BM0283, K013BM0284, K013BM0285, K013BM0286, K013BM0287, K013BM0288, K013BM0289, K013BM0290, K013BM0291, K013BM0292, K013BM0293, K013BM0294, K013BM0295, K013BM0296, K013BM0297, K013BM0298, K013BM0299, K013BM0300, K013BM0301, K013BM0302, K013BM0303, K013BM0304, K013BM0305, K013BM0306 and K016BM0322.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. || Intended for low to moderate acuity patients in the low end acute care area of the hospital.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Société-mère du fabricant (2017)
  • Source
    USFDA