Lower risk Medical device recall · FDA · Published March 1, 2021

Hitachi Medical Ultrasonic Doppler System Software Error Risk

Hitachi Medical recalls Arietta 850 ultrasound software versions 4.0.0-4.0.2 with focus errors that may exceed regulatory acoustic limits when used with C252 probes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1282-2021Medical device Hitachi Medical ›

Lower-risk 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.

Take action

Contact the company

Recalling firmHitachi Medical Systems America Inc1959 Summit Commerce Park · Twinsburg, OH 44087-2371

✎ GovInfoNow plain-language explainer

Hitachi Medical is recalling specific software versions for their Arietta 850 ultrasound systems. The error could cause acoustic output levels to exceed regulatory limits when used with certain probes, potentially affecting diagnostic safety. Read more at govinfonow.com/recall/63180-hitachi-medical-ultrasonic-doppler-system-software-error-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63180-hitachi-medical-ultrasonic-doppler-system-software-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1282-2021

Cite this page

“Hitachi Medical Ultrasonic Doppler System Software Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63180-hitachi-medical-ultrasonic-doppler-system-software-error-risk. Based on FDA recall #Z-1282-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2021%22&limit=1).

The FDA announced on March 1, 2021, that Hitachi Medical Systems America Inc. recalled the Arietta 850 ultrasonic pulsed doppler imaging system due to software errors causing excessive acoustic output. The agency classified the recall as Class II.

How to tell if you have it

Brand: Hitachi Medical
Product: Arietta 850
Software versions: 4.0.0, 4.0.1, and 4.0.2
Asset Tag: U8AR0479

The hazard

The Arietta 850 software contains errors in focus point and transducer aperture settings within the SWE function. When used with the C252 probe, this results in MI/TI acoustic output exceeding regulatory limits.

Context

GovInfoNow's records show Hitachi Medical Systems America Inc. has five other recalls on record since October 20, 2017. Other recent recalls of similar products include the Philips EPIQ Elite Ultrasound System Recall (August 7, 2026) and the PIE Medical Imaging 3mensio Workstation Software Recall (May 7, 2026).

How to tell if you have this one

Check if your Arietta 850 ultrasound system has software version 4.0.0, 4.0.1, or 4.0.2. The system is intended for use by trained medical personnel for diagnostic ultrasound evaluations.

Brand
Hitachi Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Arietta 850 software version by checking the system settings or documentation.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Mar 1, 2021Firm started the recall
Mar 19, 2021FDA classified it Class II
Mar 31, 2021Published in FDA’s Enforcement Report
Nov 4, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the system immediately?

No immediate stop is required, but you should check your software version and update if necessary.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/63180-hitachi-medical-ultrasonic-doppler-system-software-error-risk">Hitachi Medical Ultrasonic Doppler System Software Error Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1282-2021 (March 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1282-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.