FDA Device recall Z-1171-2024
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
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of 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 by Fujifilm Healthcare Americas, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1171-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-03 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fujifilm Healthcare Americas |
| Distribution | US |
Product
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.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1171-2024%22
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