FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1171-2024
·
Reported February 28, 2024
Enforcement
- Recall Number
- Z-1171-2024
- Event ID
- 93855
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- FUJIFILM Healthcare Americas Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 28, 2024
- Initiation Date
- January 3, 2024
- Classification Date
- February 21, 2024
- Address
- 81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States
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
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.
Code Info
UDI-DI 854904006008 Software versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, 7.0.000
Distribution
US domestic distribution nationwide. International distribution to Israel.
Quantity
13