Synapse CV 6 — Class II medical device recall Z-1172-2024
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2024-02-28, distributed nationwide. The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the lef
| Recall number | Z-1172-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FUJIFILM Healthcare Americas Corporation, Lexington, MA, United States |
| Recall initiated | 2024-01-03 |
| Classified | 2024-02-21 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL |
| Quantity | 8 |
| UPC / GTIN / UDI-DI | 00854904006015 |
Product
Synapse CV 6. with AR. 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1172-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.