Class II — FUJIFILM Healthcare Americas Corporation
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
|---|---|
| Registered facility | FUJIFILM Healthcare Americas Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The incorrect computed patient age is showing in VX for patients less than 3 months old. |
| 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. |
| Quantity | 104 units (69 US, 35 OUS) |
| Distribution | Domestic: 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. International: Australia, Belgium, Brazil, France, Germany, Portugal, UK |
| Initiated | 2025-02-11 |
| Classified | 2025-03-20 |
| Recall number | Z-1407-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — FUJIFILM Healthcare Americas Corporation (Z-1407-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96360/
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