FDA Device recall Z-0878-2021
Synapse PACS Software Versions 5.1 and higher
- FDA Device
- Class II
- ongoing
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of Synapse PACS Software Versions 5.1 and higher by Fujifilm Medical Systems U, citing there is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0878-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-11 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | US |
Product
Synapse PACS Software Versions 5.1 and higher
Reason
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
Identifiers
| code_info | Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7. |
|---|
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-0878-2021%22
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