Class 2 Device Recall Arietta70 Ultrasound System

• Date Initiated by Firm: May 02, 2017
• Create Date: May 12, 2017
• Recall Status: Terminated on November 19, 2018
• Recall Number: Z-2090-2017
• Recall Event ID: 77051
• 510(K)Number: K134016
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
• 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, 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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, 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• Recalling Firm/ Manufacturer: Hitachi Medical Systems America Inc; 1959 Summit Commerce Park; Twinsburg OH 44087-2371
• For Additional Information Contact: Douglas J. Thistlethwaite; 330-425-1313 Ext. 3720
• Manufacturer Reason for Recall: The strength of the arm mounting mechanism was insufficient and had to be redesigned.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 77
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYN