FDA recall Z-1172-2024

FUJIFILM Healthcare Americas Corporation · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-01-03
Report date
2024-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1172-2024