FDA Device recall Z-1261-2018
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images by Siemens Medical Solutions Usa, citing when the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1261-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-10 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
Reason
When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
Identifiers
| code_info | All Syngo.via systems with VB20A. 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-1261-2018%22
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