ClearCanvas RIS/PACS — Class II medical device recall Z-1758-2020
Terminated recall by Synaptive Medical Inc, reported 2020-04-29. A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which
| Recall number | Z-1758-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synaptive Medical Inc, Toronto, N/A, Canada |
| Recall initiated | 2020-02-26 |
| Classified | 2020-04-22 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2024-04-10 |
| Quantity | 903 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00670082000115 |
| Model numbers | SYN-0524 |
Product
ClearCanvas RIS/PACS
Reason for recall
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
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-1758-2020. 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.