FDAFDA · Food and drugs·Recall number Z-1172-2024
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Published February 28, 2024 · Recall initiated: January 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Distributor
- US domestic distribution nationwide. International distribution to Israel.
- Lot
- UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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