Z-0189-2022Class II

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

Name: Z-0189-2022 Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Creator: FujiFilm Healthcare Americas Corporation
Published: 2021-10-14
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2021-10-14 / Open, Classified / root cause: software

FDA source

FujiFilm Healthcare Americas Corporation began a recall of Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 on 2021-10-14. FDA classified it as Class II and gives the reason as "Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0189-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-14
Posted: 2021-11-02
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
Root cause tag: software
FDA root cause: Software design
Action: Fujifi Film issued Medical Device Correction Notice letter dated 10/07/21 via courier on 10/14/21. Letter states reason for recall, health risk and action to take: Customers/Users are advised to accept the corrected software and manual as soon as available. Advisory Notification applies to all customers and distributors of the ARIETTA 850 systems with software version V1.0.0 through V4.1.3, See following page for complete list of affected systems. We will contact you to set up time to update the software and provide the revised manual. (7) Other Information: For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email [email protected]
Quantity in commerce: 15 units
Distribution: Nationwide
Product codes and lots: Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0189-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-02
Z-0190-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-02
Z-0191-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-02

Product code IYN

K191233Class IIArietta 750Hitachi Healthcare Americas / cleared 2019-08-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)