FDA Device recall Z-1349-2016
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive…
- FDA Device
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive… by Siemens Medical Solutions Usa, citing to inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1349-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-18 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Reason
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Identifiers
| code_info | Model # 10014063 |
|---|
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-1349-2016%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.