Fujifilm recalls PACS software versions 7.0.0 and 7.0.1 due to clinical reporting errors when ventricular traces are changed by different users. Affected users should check their software version and contact Fujifilm for updates.
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
Fujifilm recalls two software versions (7.0.0 and 7.0.1) for PACS systems because changing ventricular traces in studies by different users can cause clinical reporting errors. This means reports might be inaccurate, potentially affecting patient care decisions.
When different users change ventricular traces in a study, the software fails to update clinical reports correctly. This could lead to inaccurate patient data, but does not cause immediate harm or injury.
Healthcare providers using Fujifilm Synapse PACS software versions 7.0.0 or 7.0.1 for clinical reporting. Those most at risk are users who modify study data in real-time across multiple users.
Check if your Fujifilm Synapse PACS software version is 7.0.0 or 7.0.1. The software is used as a web-based application on compatible PCs connected to a Fujifilm Synapse PACS server.
Identify your software version by checking the application settings or documentation.
Reach out to Fujifilm Medical Systems for guidance on updates or alternatives.
No, this recall is for potential clinical reporting errors, not immediate safety risks. The software does not cause injury or death.
Check your software version in the application settings or documentation. Versions 7.0.0 and 7.0.1 are affected.
No, but you should check your version and contact Fujifilm for updates to avoid potential errors.
We’ve drafted a message you can send Fujifilm to request your refund or repair — edit it as you like.
Subject: Recall Z-0918-2021 — Fujifilm Fujifilm Hello, I own a Fujifilm that is covered by recall Z-0918-2021 from Fujifilm. 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.
