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.
Reported: February 28, 2024 Initiated: January 3, 2024 #Z-1171-2024
Product Description
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.
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.
Details
- Recalling Firm
- FUJIFILM Healthcare Americas Corporation
- Units Affected
- 13
- Distribution
- US domestic distribution nationwide. International distribution to Israel.
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by FUJIFILM Healthcare Americas Corporation. Units affected: 13.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2024. Severity: Moderate. Recall number: Z-1171-2024.
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