Synapse PACS Software Versions 5 — Class II medical device recall Z-0878-2021
Ongoing recall by Fujifilm Medical Systems U.S.A., Inc., reported 2021-01-27, distributed nationwide. There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Addition
| Recall number | Z-0878-2021 |
|---|---|
| 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 | 2020-09-11 |
| Classified | 2021-01-16 |
| Reported by FDA | 2021-01-27 |
| Distributed | Nationwide (US) |
| Quantity | 235 |
Product
Synapse PACS Software Versions 5.1 and higher
Reason for recall
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
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-0878-2021. 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.