Synapse PACS — Class II medical device recall Z-1269-2024
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2024-03-13, distributed nationwide. Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combi
| Recall number | Z-1269-2024 |
|---|---|
| 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 | 2024-01-10 |
| Classified | 2024-03-07 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CO, DE, EC, ES, FR, GB, IN, IT, MX, NL, PT, QA, TH, TR |
| UPC / GTIN / UDI-DI | 00854904006008 |
Product
Synapse PACS - Version 7.1.000US
Reason for recall
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
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-1269-2024. 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.