# FDA recall Z-1172-2024

> **FUJIFILM Healthcare Americas Corporation** · Class II · device recall initiated 2024-01-03.

## 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

- **Recall number:** Z-1172-2024
- **Recalling firm:** FUJIFILM Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-03
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1172-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1172-2024. Source: US FDA. Licensed CC0.

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