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FUJIFILM Healthcare Americas Corporation recalls Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the proces
Recalled February 28, 2024 · FDA recall Z-1171-2024 · FUJIFILM Healthcare Americas
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. · FDA Class II
Units
13
Sold at
US domestic distribution nationwide. International distribution to Israel.
Description
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.
Product
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.
Manufacturer(s)
FUJIFILM Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →