FDA Device recall Z-1303-2018
Syngo.via
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of Syngo.via by Siemens Medical Solutions Usa, citing A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1303-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-08 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
Syngo.via. Medical Device Software. Picture archiving and communications system.
Reason
A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Identifiers
| code_info | Model Number 10496180 |
|---|
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-1303-2018%22
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