FDA Device recall Z-2275-2012
syngo.plaza, Model number 10592457
- FDA Device
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of syngo.plaza, Model number 10592457 by Siemens Medical Solutions Usa, citing there is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2275-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-18 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Reason
There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
Identifiers
| code_info | Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146. |
|---|
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-2275-2012%22
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