Synapse PACS — Class II medical device recall Z-1348-2021
Ongoing recall by Fujifilm Medical Systems U.S.A., Inc., reported 2021-04-14, distributed nationwide. The wrong patient information may be displayed in the viewer or PowerJacket.
| Recall number | Z-1348-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Lexington, MA, United States |
| Recall initiated | 2021-03-02 |
| Classified | 2021-04-02 |
| Reported by FDA | 2021-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BM, BR, CA, CH, CL, CO, CR, CZ, DE, ES, FI, FR, GB, GR, GT, HK, ID, IL, IN, IT, JO, JP, KW, MT, MX, MY, NL, PE, PH, PK, PL, PT, RU, SA, SG, SI, SK, SV, TH, TR, UY, ZA |
| Quantity | 839 systems |
Product
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Reason for recall
The wrong patient information may be displayed in the viewer or PowerJacket.
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-1348-2021. 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.