Z-1282-2021Class II

Ultrasonic pulsed doppler imaging system -

Name: Z-1282-2021 Ultrasonic pulsed doppler imaging system -
Creator: Hitachi Medical Systems America Inc
Published: 2021-03-01
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2021-03-01 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound... on 2021-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1282-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-01
Posted: 2021-03-19
Terminated: 2021-11-04
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: 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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On 3/1/2021, Hitachi issued an Urgent Medical Device Correction notice to customers for the Arietta 850 system operating with software version 4.0.2 that utilizes SWE function with the C252 probe. The R&D department of Hitachi Ltd. (Manufacturer) has identified an error in the focus point and transducer aperture settings in the SWE function at the manufacturer facility. This error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: Asset Tag: U8AR0479 Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1282-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1282-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-19

Product code IYN

K183456Class IIAloka Arietta 850Hitachi Healthcare Americas / cleared 2019-01-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)