FDA Device recall Z-0073-2017
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management sys…
- FDA Device
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management sys… by Fujifilm Medical Systems U, citing image data for a patients image may not be correct.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0073-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-15 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | US |
Product
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Reason
Image data for a patients image may not be correct
Identifiers
| code_info | Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0073-2017%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.