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.
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.
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.
The software error causes the ultrasound system to produce higher than allowed acoustic output levels when used with the C252 probe. This could potentially lead to unsafe diagnostic results if the output exceeds regulatory limits.
Healthcare professionals using the Arietta 850 ultrasound system with affected software versions. Doctors and sonographers who perform diagnostic ultrasounds are most at risk.
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.
Verify your Arietta 850 software version by checking the system settings or documentation.
Software versions 4.0.0, 4.0.1, and 4.0.2 of the Arietta 850 system.
The error may cause acoustic output levels to exceed regulatory limits when used with the C252 probe, potentially affecting diagnostic safety.
No immediate stop is required, but you should check your software version and update if necessary.
We’ve drafted a message you can send Hitachi Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1282-2021 — Hitachi Medical Hitachi Medical Hello, I own a Hitachi Medical that is covered by recall Z-1282-2021 from Hitachi Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
