Events

Retiro De Equipo (Recall) de Device Recall Arietta70 Ultrasound System

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 Hitachi Medical Systems America 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
    77051
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2090-2017
  • Fecha de inicio del evento
    2017-05-02
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154883
  • 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    The strength of the arm mounting mechanism was insufficient and had to be redesigned.
  • Acción
    An Urgent: Device Correction Notice was sent via overnight carrier on 5/5/17. The Notice identified the affected product and problem. The firm will replace the Monitor Arm to correct the issue at no cost to the customer. If the problem occurs, customers are to call 800-800-4925 for immediate service. Hitachi Service will update the hardware at each site. Customers can contact recalls@hitachihealthcare.com with questions, comments, or requests regarding the Notice.

Device

Device Recall Arietta70 Ultrasound System
  • Modelo / Serial
    203A5592, 203A5593, 203A5594, 203A5595, 203A5596, 203A5599, 203A5615, 20A5622, 203A5623, 203A5624, 203A5625, 203A5626, 203A563 l , 203A5632, 203A5633, 203A5637, 203A5643, 203A5652, 203A5661, 203A5668, 203A5675, 203A9363, 203A9364, 203A9365, 203A9367, 203A9369, 203A9372, 203A9373, 203A9374, 203A9375, 203A9376, 203A9377, 203A9378, 203A9379, 203D7204, 203D7205, 203D7206, 203D7262, 203D7263, 203D7264, 203D7266, 203D7267, 203D7268, 203D7269, 203D7270, 203D7272, 203D7273, 203D7274, 203D7275, 203D7276, 203D7277, 203D7278, 203D7279, 203D7280, 203D7281 , 203D7282, 203D7283, 203D7284, 203D7285, 203D7286, 203D7287, 203D7288, 203H4348, 203H4349, 203H4350, 203H4351 , 203H4352, 203H4353, 203H4354, 203H4355, 203H4356, 203H4357, 203H4358, 203H4359, 203H4360, 203H4361, 203H4362, 203H4363, 203H4364, 203H4365, 203H4366, 203H4367, 203H4368, 203H4369, 203H4370, 203H4371, 203H4372, 203H4373, 203H4374, 203H4375, 203H4379, 203H4380, 203H4381 , 203H4382, 203H4383, 203H4384, 203H4385, 203H4386, 203H4387, 203H4388, 203H4389, 203H4390, 203H4408, 203H4409, 203H441 l , 203H4412, 203H44 13, 203H4414, 203H4415, 203H4416, 203H4417, 203H4418, 203H4419, 203H4420, 203H442 1, 203H4422, 203H4423, 203H4424, 203H4425, 203H4426, 203H4427, 203H4428, 203H4429, 203H4430, 203H4431, 203H4432, 203H4433, 203H4434, 203H4435, 203H4436, 203H4437, 203H4438, 203H4439, 203H4440, 203H4441 , 203H4442, 203H4443, 203H4444, 203H4445, 203H4446, 203H4447, 203N4125, 203N4126, 203N4127, 203N4128, 203N4129, 203N4 130, 203N413 l, 203N4132, 203N4133, 203N4134, 203N4135, 203N4136, 203N4137, 203N4138, 203N4139, 203N4140, 203N4141, 203N4143, 203N4144, 203N4145, 203N4146, 203N4147, 203N4148, 203N4149, 203N4 150, 203N4 151, 203N4152, 203N4153, 203N4154, 203N4155, 203N4156, 203N4157, 203N4158, 203N4159, 203R0583, 203R0584, 203R0585, 203R0586, 203R0587, 203R0588, 203R0589, 203R0590, 203R0591, 203R0592, 203R0593, 203R0594, 203R0595, 203R0596, 203R0597, 203UJ482, 203UI483, 203UJ527, 203UJ528, 203Ul529, 203UJ530, 203UJ531, 203UJ532, 203UJ533, 203UI534, 203Ul535, 203UJ536, 203UJ537, 203UI538, 203UJ539, 203Ul541, 203UJ542, 203UI543, 203Ul544, 203UJ545, 203UJ546, 203UJ547, 203Ul548, 203UJ549, 203Ul550, 203UI551, 203Ul552, 203Ul 553, 203UJ554, 203UJ555, 203UI556, 203U4747, 203U4748, 203U4749, 203U4750, 203U4751 , 203U4752, 203U4753, 203U4754, 203U4755, 203U4756, 203U4757, 203U4758, 203U4759, 203U4760, 203U4761, 203U4762, 203U4763, 203U4764, 203U4765, 203U4766, 203U4767, 203U4768, 203U4769, 203U4770, 203U4771, 203U4772, 203U4773, 203U4774, 203U4775, 203U4776, 203U4777, 203U4778, 203U4779, 203U4780, 203U4781, 203U4782, 203U4783, 203U4784, 203U4785, 203U4786, 203U4787, 203U4788, 203U4789, 203U4790, 203U4791 , 203U4792, 203U4793, 203U4794, 203U4795, 203U4796, 203U4797, 203U4798, 203U4799, 203U4800, 203U4801, 203U4802, 203U4803, 203U4804, 203U4805, 203U4806, 203U4807, 203U4808, 203U4809, 203U4810, 203U4811 , 203U4812, 203U4813, 203U4814, 203U4815, 203U4816, 203U4817, 203U4818, 203U4819, 203U4820, 203U4821, 203U4822, 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20484623,20484624,20484625,20484626, 20484627, 20484628, 20484629, 20484630, 20484631 , 20488549,20488550, 20488551, 20488552, 20488553,20488554, 20488555, 20488556, 20488557, 20488558, 20488561 , 20488562, 20493248, 20493249,20493250, 20493251,20493252,20493253, 20493254, 20493255,20493256,20493257, 20499169,20499170,20499171,20499172, 20499173, 20499174, 20499175, 20499176,20499177, 20499178, 20499179,20499180, 20499181,20499182,20499183,20499184, 20499185, 20499186, 20499187, 204A4548, 204A4549, 204A4550, 204A4551, 204A4552, 204A6822, 204A6823, 204A6824, 204A6825, 204A6826, 204A6827, 204A6828, 204A6829, 204A6830, 204A6831 , 204A6832, 204A6833, 204A6834, 204A6835, 204A6836, 204A6837, 204A6838, 204A6839, 204A6840, 204A6841 , 204A6842, 204A6843, 204A6844, 204A6845, 204A6846, 204A6847, 204A6848, 204A6849, 204A6850, 204A6851 , 204A6853, 204B9343, 204B9344, 204B9345, 204B9346, 204B9347, 204B9348, 204B9349, 204B9915, 204B9916, 204B9917, 204B9918, 204B9919, 204B9920, 204B9921 , 204B9922, 204B9923, 204B9924, 204B9925, 204B9926, 204B9930, 204B9931 , 204B9932, 204B9933, 204B9934, 204B9935, 204B9936, 204B9937, 204B9938, 204B9939, 204B9940, 204B9941 , 204B9942, 204B9943, 204B9944, 204B9945, 204B9946, 204B9947, 204B9948, 204B9949, 204B9950, 204B9951 , 204B9952, 204B9953, 204B9954, 204E0458, 204E0459, 204E0460, 204E0461 , 204E0462, 204E0463, 204E0464, 204E0465, 204E0466, 204E0467, 204E0468, 204E0469, 204E0470, 204E0471 , 204E0472, 204E0473, 204E0474, 204E0475, 204E0476, 204E0477, 204E0478, 204E0479, 204E0480, 204E0481, 204E0482, 204E0486, 204E0487, 204E0488, 204E0489, 204E0490, 204E0491 , 204E0492, 204E0493, 204E0494, 204E0495, 204E0496, 204E0497, 204E0498, 204E0499, 204E0500, 204E0501, 204E0502, 204E0503, 204E0504, 204E0505, 204E0506, 204E0507, 204F4669, 204F4670, 204F4671, 204F4672, 204F4673, 204F4674, 204F4675, 204F4676, 204F4677, 204F4678, 204F4679, 204F4680, 204F4681, 204F4682, 204F4683, 204F4684, 204F4685, 204F4686, 204F4687, 204F4688, 204F4689, 204F4690, 204F4691, 204F4692, 204F4693, 204F4694, 204F4695, 204F4696, 204F4697, 204F4698, 204F4699, 204F4700, 204F4701 , 204F4702, 204F4703, 204F4704, 204F4705, 204F4706, 204F4707, 204F4708, 204F4709, 204F4710, 204F4711, 204F4712, 204F4713, 204F4714, 204F4715, 204F4716, 204F4717, 204F4718, 204F4719, 204F4720, 204F4721, 204F4722, 204F4723, 204F4724, 204F4725, 204F4726, 204F4727, 204F4728, 204F4729, 204F4730, 204F4731 , 204F4732, 204F4733, 204F4734, 204F4735, 204F4736, 204F4737, 204F4741, 204F4743, 204F4744, 204F4745, 204F4746, 204F4747, 204F4748, 204F4749, 204F4750, 204F4751 , 204F4752, 204F4753, 204F4754, 204F4755, 204F4756, 204F4757, 204F4758, 204F4759, 204F4760, 204F4761 , 204F4762, 204F4763, 204F4764, 204F4765, 204F4766, 204F4767, 204F4768, 204G8864, 204G8865, 204G8866, 204G8867, 204G8868, 204G8869, 204G8870, 204G8871, 204G8877, 204G8878, 204G8881 , 204H0967, 204H0968, 204H0969, 204H0970, 204H0971 , 204H0972, 204H0973, 204H0974, 204H0975, 204H0976, 204H0977, 204H0978, 204H0979, 204H0980, 204H0981, 204H0982, 204H0983, 204H0984, 204H0985, 204H0986, 204H0987, 204H0988, 204H0989, 204H0990, 204H0991, 204H0992, 204H0993, 204H0994, 204H0995, 204H0996, 204H0997, 204H0998, 204H0999, 204HI000, 204H1001, 204Hl002, 204H1018, 204Hl019, 204Hl020, 204Hl021, 204Hl022, 204HI023, 204H1024, 204H1025, 204H1026, 204Hl027, 204H1028, 204Hl029, 204Hl030, 204H1031 , 204H!032, 204Hl033, 204H1034, 204Hl035, 204HI036, 204HI037, 204H1038, 204HI039, 204Hl040, 204Hl041, 204H1042, 204HI043, 204HI044, 204H1045, 204Hl053, 204Hl054, 204HI055, 204Hl056, 204Hl 057, 204HI058, 204H1059, 204H1060, 204Hl061, 204Hl062, 204HI063, 204Hl064, 204H1065, 204Hl066, 204H1067, 204H1068, 204Hl069, 204Hl070, 204H1071, 204H1072, 204H1073, 204H1074, 204H1075, 204Hl076, 204Hl077, 204Hl078, 204Hl079, 204Hl 080, 204Hl081, 204HJ082, 204HI083, 204HI084, 204H1085, 204HI086, 204HJ087, 204H1088, 204Hl089, 204Hl090,204Hl091 , 20416742, 20416743, 20416744, 20416745, 20416746, 20416747, 20416748, 20416749, 20416750, 20416751 , 20416752, 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V0011072, VOOl 1073, VOOIJ074, VOOl 1090, V0011091, V0011092, VOOI 1093 XOOC0944, XOOC0945, XOOC0946, XOOC0947, XOOC0948, XOOC0949, XOOC0950, XOOC0951, XOOC0952, XOOC0953, XOOC0954, XOOC0955, XOOC0956, XOOC0957, XOOC0958, XOOC0959
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.
  • Descripción del producto
    Arietta 70 Ultrasound System || Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • Dirección del fabricante
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    USFDA