FUJIFILM Healthcare Americas Corporation: Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. 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: 13 Lot/code info: UDI-DI 854904006008 Software versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, 7.0.000

UPC codes

854904006008

Source

Official record: FDA (Device enforcement) ↗

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