FDA Device recall Z-1758-2020
ClearCanvas RIS/PACS
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of ClearCanvas RIS/PACS 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-1758-2020 |
| 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
ClearCanvas RIS/PACS
Reason
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Identifiers
| code_info | ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1 |
|---|
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-1758-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.