Events

Device Recall Arietta70 Ultrasound System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hitachi Medical Systems America 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
    77051
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2090-2017
  • 사례 시작날짜
    2017-05-02
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154883
  • 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    The strength of the arm mounting mechanism was insufficient and had to be redesigned.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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, 203U4823, 203U4824, 203U4825, 203U4826, 203U4827, 203U4828, 203U4829, 203U4830, 203U4831, 203U4832, 203U4833, 203U4834, 203U4835, 203U4836, 20421803, 20421804,20421805, 20421806, 20421807, 20421808, 20421809,20421810, 20422674, 20422675, 20422677, 20456707,20456709, 20456710,20456711,20456827, 20456828, 20456829,20456830, 20456831,20456832, 20456833,20456834,20456835, 20456836,20456837, 20456838, 20456839, 20456840, 20456841,20456842, 20456843,20456844,20456845,20456846, 20456847,20456848, 20456849, 20456850, 20456851, 20456852, 20456853, 20475191 , 20475192, 20475193,20475194,20475195, 20475196, 20475197,20475198, 20475199, 20475200,20475201, 20475202,20475203, 20475204, 20475205, 20475206,20475207, 20475208, 20475209, 20475210, 20475211,20475212, 20475213, 20475214, 20475215,20475216, 20475217, 20475218, 20475219, 20475220,20484497,20484498, 20484499, 20484501, 20484612,20484613, 20484614, 20484615,20484616, 20484617, 20484618, 20484619, 20484620, 20484621,20484622, 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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.
  • 제품 설명
    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
  • 제조사 주소
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • 제조사 모회사 (2017)
    Hitachi Ltd
  • Source
    USFDA