Z-2090-2017Class II

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

Name: Z-2090-2017 Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the...
Creator: Hitachi Medical Systems America Inc
Published: 2017-05-02
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-05-02 / Terminated / root cause: design

FDA source

Hitachi Medical Systems America Inc began a recall of Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation on 2017-05-02. FDA classified it as Class II and gives the reason as "The strength of the arm mounting mechanism was insufficient and had to be redesigned". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2090-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-02
Posted: 2017-05-12
Terminated: 2018-11-19
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Root cause tag: design
FDA root 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 [email protected] 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.
Product codes and lots: 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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2090-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2090-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code IYN

K134016Class IIArietta 70/Arietta S70/arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical / cleared 2014-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)