Class II — Synaptive Medical Inc
| Recalling firm | Synaptive Medical Inc |
|---|---|
| Registered facility | Synaptive Medical Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. |
| Product | Synaptive ImageDrive Clinical |
| Quantity | 28 units |
| Distribution | US |
| Initiated | 2020-02-26 |
| Classified | 2020-04-22 |
| Terminated | 2024-04-10 |
| Recall number | Z-1759-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Synaptive Medical Inc (Z-1759-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85216/
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