Official recall record
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 imag
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2024-01-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 854904006008
- Brand on record
- FUJIFILM Healthcare Americas Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 4 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2024-01-10 · US FDA — Medical Devices
Synapse PACS - Version 7.2.100 - 2024-01-10 · US FDA — Medical Devices
Synapse PACS - Version 7.1.000 - 2024-01-10 · US FDA — Medical Devices
Synapse PACS - Version 7.2.000 - 2024-01-10 · US FDA — Medical Devices
Synapse PACS - Version 7.1.000US
Other recalls from this brand
- 2026-01-09 · US FDA — Medical Devices
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
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