FDA Device recall Z-1759-2020
Synaptive ImageDrive Clinical
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Synaptive ImageDrive Clinical by Synaptive Medical, citing A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1759-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-26 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Synaptive Medical |
| Distribution | n/a |
Product
Synaptive ImageDrive Clinical
Reason
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Identifiers
| code_info | ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1759-2020%22
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