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 | Software issue may cause the ruler measurement to be inaccurate. |
| Product | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system |
| Quantity | 6 units |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia. |
| Initiated | 2026-07-22 |
| Classified | 2026-08-26 |
| Recall number | Z-3030-2026 |
| 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-3030-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99529/
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