Z-0576-2015Class II

Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS

Name: Z-0576-2015 Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-11-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-11-11 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display... on 2014-11-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0576-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-11
Posted: 2014-12-15
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens sent a Safety Advisory notices letter dated November 11, 2014 to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions call 1-888-826-9702.
Quantity in commerce: 149
Distribution: US Nationwide Distribution
Product codes and lots: 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, 100196, 100306, 100232, 100185, 100596, 100256, 100599, 100193, 100257, 100198, 100226, 100198, 100181, 100029, 100253, 100301, 100132, 100247, 100248, 100139, 100215, 100230, 100146, 100212, 100539.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0576-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0576-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)