FDA Device recall Z-0576-2015
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) in…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) in… by Siemens Medical Solutions Usa, citing printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical prin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0576-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-11 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Reason
Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.
Identifiers
| code_info | model numbers: 10592457, 10863171, 10863172, 10863173, 7502029 , 10496279, with multiple serial numbers: 1187, 3182, 31…model numbers: 10592457, 10863171, 10863172, 10863173, 7502029 , 10496279, with multiple serial numbers: 1187, 3182, 3183, 3212, 3206, 3207, 1361, 10870, 12068, 10733, 3052, 2323, 1496, 3246, 2254, 1089, 1213, 14898, 2626, 1624, 2365, 3087, 13504, 11795, 13921, 2971, 12271, 13090, 9594, 2890, 1372, 12789, 3062, 1856, 2500, 13591, 14005, 3017, 3010, 1373, 9792, 13727, 1374, 14292, 2562, 3165, 2098, 2698, 3211, 2769, 1382, 1165, 2310, 13480, 2324, 2751, 2901, 2897, 2981, 3093, 3050, 3085, 14328, 100544, 100566, 100198, 100600, 100259, 100135, 100133, 100031, 100084, 100233, 200308, 200309, 200310, 200311, 200312, 200313, 200314, 200315, 200316, 200317, 200318, 200319, 200320, 200321, 200322, 200323, 200324, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100245, 100314, 200277, 100139, 100177, 100027, 100601, 100170, 100025, 100174, 100033, 100186, 100189, 100190, 100191, 100192, 100195, |
|---|
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-0576-2015%22
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