FUJIFILM Synapse PACS software v7 — Class II medical device recall Z-3030-2026
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2026-09-02, distributed nationwide. Software issue may cause the ruler measurement to be inaccurate.
| Recall number | Z-3030-2026 |
|---|---|
| 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 | 2026-07-22 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 6 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00854904006008 |
| Serial numbers | CV-00272120, CV-00494020-38, CV-0080080176, CV-01-80102732, CV-01318490, CV-80057523 |
Product
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Reason for recall
Software issue may cause the ruler measurement to be inaccurate.
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-3030-2026. 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.