FDA-Device2024-02-28Class II
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FUJIFILM Healthcare Americas Corporation
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.
Sold states
US domestic distribution nationwide. International distribution to Israel.
Affected count
8
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1172-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief