Synapse PACS Software Version 7 — Class II medical device recall Z-1407-2025
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2025-03-26, distributed in AR, AZ, CA, CO, CT, FL, GA, HI…. The incorrect computed patient age is showing in VX for patients less than 3 months old.
| Recall number | Z-1407-2025 |
|---|---|
| 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 | 2025-02-11 |
| Classified | 2025-03-20 |
| Reported by FDA | 2025-03-26 |
| Distributed | AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY |
| Countries outside the US | AU, BE, BR, DE, FR, GB, PT |
| UPC / GTIN / UDI-DI | 00854904006008 |
Product
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Reason for recall
The incorrect computed patient age is showing in VX for patients less than 3 months old.
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-1407-2025. 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.