Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.)...
FDA Device Recall #Z-2090-2017 — Class II — May 2, 2017
Recall Summary
| Recall Number | Z-2090-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 2, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hitachi Medical Systems America Inc |
| Location | Twinsburg, OH |
| Product Type | Devices |
| Quantity | 77 |
Product Description
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Reason for Recall
The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Distribution Pattern
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 Information
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
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.