FDA Device recall Z-1348-2021
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC m…
- FDA Device
- Class II
- ongoing
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC m… by Fujifilm Medical Systems U, citing the wrong patient information may be displayed in the viewer or PowerJacket.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1348-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-02 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | US |
Product
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Reason
The wrong patient information may be displayed in the viewer or PowerJacket.
Identifiers
| code_info | Software version: 5.1 to 5.7.200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1348-2021%22
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