FUJIFILM Healthcare recalls specific versions of Synapse Cardiology PACS software due to potential incorrect left ventricle mass calculations, which could lead to misdiagnosis or incorrect treatment.
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
FUJIFILM Healthcare is recalling specific versions of their Synapse Cardiology PACS software. The software may calculate left ventricle mass incorrectly, which could lead to misdiagnosis or incorrect treatment plans and serious health consequences.
The software may calculate left ventricle mass incorrectly, which could lead to misdiagnosis or incorrect treatment plans. This risk is serious enough to cause long-term health consequences or serious deterioration of health if the incorrect calculation is used as a main factor for diagnosis.
Healthcare providers using the recalled software versions for medical imaging processing are most at risk. Patients receiving diagnoses based on these software versions could be affected.
Check if you have Synapse Cardiology PACS software versions 7.3.0, 7.2, 7.1, or 7.0. The software is a web-based application used for processing medical images.
Contact FUJIFILM Healthcare to get the latest software version that fixes the issue.
Synapse Cardiology PACS versions 7.3.0, 7.2, 7.1, and 7.0 are affected.
The software may calculate left ventricle mass incorrectly, which could lead to misdiagnosis or incorrect treatment plans and serious health consequences.
Yes, FUJIFILM Healthcare offers updated software versions to fix the issue.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1171-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1171-2024 from FUJIFILM 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.
