Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
This recall has been terminated (originally issued May 2, 2017).
- Recall Initiated
- May 2, 2017
- Terminated
- November 19, 2018
- Recall Number
- Z-2090-2017
- Quantity
- 77
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Distribution
Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.
Lot / Code Info
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, 20416753, 20416754, 20416755, 20416756, 20416757, 20416758, 20416759, 20416760, 20416761, 20416777, 20416778, 20416779, 20416780, 20416781, 20416782, 20416783, 20416784, 20416785, 20416786, 20416787, 20416788, 20416789, 20416806, 20416807, 20416808, 20416809, 20416810, 20416811 , 20416823, 20416824, 20416825, 20416826, 204J6827, 20416828, 204J6829, 20416830, V0006403, V0008450, V0008451 , V0008452, V0008453, V0008454, V0010475, V0010476, V0010477, V0010478, VOOJ0479, V0010480, V0010481, VOOI0482, V0010483, VOOJ0484, V0010485, V0010486, V0010487, V0010488, V0010489, VOOI0490, V001049l , V0010492, VOOI0493, V0010494, VOOJ0495, V0010496, V0010497, V0010498, VOOJ0499, V0010500, VOOI0501 , V0010502, V0010503, V0010504, V0010505, V0010506, V0010507, V0010508, V0010509, V0010510, VOOI0511, V0010512, V0010513, V0010514, V0010515, V0010516, V0010517, V0010518, V0010519, V0010520, V0010521, V0010522, V0010523, V0010524, VOOI0525, V0010526, VOOJ0527, V0010528, V0010529, V0011070, V0011071 , 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
Root Cause
Device Design
Action Taken
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.