Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

Class I - Dangerous

🏥 Medical Devices Recalled: May 2, 2017 Hitachi Medical Systems America Diagnostic Equipment

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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, 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Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Hitachi Medical Systems America Inc
Reason for Recall:: The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

Product Codes/Lot Numbers:

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, 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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, 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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

Distribution:

Distributed in: AZ, CA, FL, HI, IL, MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2090-2017

Related Recalls

Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.

Hitachi Medical Systems America

Class I - Dangerous

Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

Mar 1, 2021 Diagnostic Equipment Nationwide View Details →

UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.

Hitachi Medical Systems America

Class I - Dangerous

These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

Jan 31, 2020 Diagnostic Equipment View Details →

Hitachi Scenaria Whole-body X-ray CT System

Hitachi Medical Systems America

Class I - Dangerous

There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.

Oct 16, 2019 Other Medical Devices View Details →