FUJIFILM Healthcare recalls Synapse CV 6. with AR software versions 6.0.0-6.2.2 for potential misdiagnosis from incorrect left ventricle mass calculations. Affected users should contact the manufacturer for details.
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 Synapse CV 6. with AR software versions 6.0.0 through 6.2.2 because incorrect calculations of left ventricle mass could lead to misdiagnosis or incorrect treatment. This risk may cause serious health issues if the software is used for critical medical decisions.
The software may calculate the left ventricle mass incorrectly, which could lead to misdiagnosis or incorrect treatment plans. If this error is used as a primary factor in medical decisions, it might cause serious health consequences or long-term health deterioration.
Healthcare providers using the Synapse CV 6. with AR software for medical imaging analysis are most at risk. Patients receiving diagnoses based on this software could be affected if the calculations are incorrect.
Check for software versions 6.0.0 through 6.2.2 in the Synapse CV 6. with AR product. The software is a web-based application for processing medical images.
Reach out to FUJIFILM Healthcare Americas Corporation for specific guidance on the recall and next steps.
Software versions 6.0.0 through 6.2.2.
Yes, incorrect left ventricle mass calculations could lead to misdiagnosis or incorrect treatment, potentially causing serious health consequences.
Check the software version in Synapse CV 6. with AR, which is a web-based application for medical imaging processing.
We’ve drafted a message you can send FUJIFIL: Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1172-2024 — FUJIFIL: Healthcare FUJIFIL: Healthcare Hello, I own a FUJIFIL: Healthcare that is covered by recall Z-1172-2024 from FUJIFIL: 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.
