Hitachi Healthcare recalls VidiStar PACS & DICOM Viewer Software versions 3.10.5 and : intermixed patient images in studies could cause misdiagnosis.
The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.
Hitachi Healthcare is recalling VidiStar PACS & DICOM Viewer Software versions 3.10.5 and 3.10.6 because the secure filesystem client software may show images from multiple patients in a single study. This could lead to misdiagnosis if healthcare providers accidentally use images from the wrong patient.
The secure filesystem client software in the VidiStar system may mix images from different patients into a single study. This could cause healthcare providers to accidentally use images from the wrong patient during diagnosis, potentially leading to misdiagnosis.
Healthcare providers using VidiStar software versions 3.10.5 or 3.10.6 for medical imaging are most at risk. Patients receiving imaging services through this system could also be affected if images are mislabeled.
Check for VidiStar PACS & DICOM Viewer Software versions 3.10.5 or 3.10.6. The software is used in medical imaging systems for hospitals and clinics.
Identify your software version by checking the version number in the VidiStar system settings.
The software may cause images from multiple patients to appear in a single study, which could lead to misdiagnosis if healthcare providers use the wrong images. However, this is not an immediate safety hazard.
Check your software version. If you have versions 3.10.5 or 3.10.6, contact Hitachi Healthcare for guidance on updating or replacing the software.
The recall record does not specify a fix or update process. Contact Hitachi Healthcare directly for instructions.
We’ve drafted a message you can send Hitachi Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2992-2018 — Hitachi Healthcare Hitachi Healthcare Hello, I own a Hitachi Healthcare that is covered by recall Z-2992-2018 from Hitachi Healthcare. 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.
