Z-1171-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- January 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
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.
Distribution Pattern
US domestic distribution nationwide. International distribution to Israel.
Code Information
UDI-DI 854904006008 Software versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, 7.0.000