medical Class II Updated 2024-02-28

FUJIFILM Healthcare Americas Corporation recalls Synapse CV 6. with AR. A web-based application as the pri

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
View official government recall

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