Medical Device Recall: 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.
FUJIFILM Healthcare Americas Corporation · January 3, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
13
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1171-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.