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

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.

Details from the source

Reason for recall: 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. Distribution: US domestic distribution nationwide. International distribution to Israel. Quantity: 8 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

UPC codes

00854904006015

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.