FDA Device recall Z-1975-2013
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system by Siemens Medical Solutions Usa, citing siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mamm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1975-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-04 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Reason
Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
Identifiers
| code_info | Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional se…Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539. |
|---|
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-1975-2013%22
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