Hitachi recalls specific software versions of its PROBEAT-V radiation therapy systems due to potential target position discrepancies in 3D3D matching mode. Affected units may require correction to prevent treatment errors.
There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
Hitachi is recalling specific software versions of its PROBEAT-V radiation therapy systems. The software could cause target position errors during treatment planning, which might lead to inaccurate radiation delivery.
The software's 3D3D matching mode may show incorrect target positions during radiation treatment planning. This could result in inaccurate radiation delivery to the tumor, potentially affecting treatment effectiveness.
Patients receiving proton therapy using the affected software versions are most at risk. Healthcare providers using the PROBEAT-V systems with these software versions should check for the recall.
Check if your PROBEAT-V radiation therapy system has software versions 4.8.1S or 5.1M. The recall covers units sold with these specific software versions starting from 2015.
Identify your PROBEAT-V system's software version to see if it is 4.8.1S or 5.1M.
If you have the affected software, contact your healthcare provider for instructions on updating to a safe version.
Software versions 4.8.1S and 5.1M of the PROBEAT-V radiation therapy system.
Check if your PROBEAT-V system has software versions 4.8.1S or 5.1M, as these were sold starting from 2015.
No, but you should check your software version and contact your healthcare provider for updates to prevent treatment errors.
We’ve drafted a message you can send Hitachi to request your refund or repair — edit it as you like.
Subject: Recall Z-1892-2019 — Hitachi Hitachi Hello, I own a Hitachi that is covered by recall Z-1892-2019 from Hitachi. 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.
