FDA Device recall Z-1972-2015
SYNGO IMAGING (VERSION V30 and V31)
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of SYNGO IMAGING (VERSION V30 and V31) by Siemens Medical Solutions Usa, citing during certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1972-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-11 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | NC, NE |
Product
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is 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
During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
Identifiers
| code_info | model number: 10014064 serial numbers: 5846 5847 4333 4334 4335 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1972-2015%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.