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FDAJanuary 3, 2024device

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

fujifilm healthcare americasfujifilmfujifilm healthcare

UPCs

00854904006015

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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