Retiro De Equipo (Recall) de HillRom Basic Care Bed

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Hill-Rom, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56018
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2170-2010
  • Fecha de inicio del evento
    2009-09-16
  • Fecha de publicación del evento
    2010-08-03
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Manual Bed - Product Code FNJ
  • Causa
    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.
  • Acción
    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

  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

  • Dirección del fabricante
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA