CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

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

Siemens Medical Solutions USA is recalling Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS, distributed nationwide in the US. The recall was initiated on 11 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmodel 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.

Quantity recalled149

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0576-2015
FDA event ID: 69802
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2014
FDA classified: 9 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

11 Nov 2014	Recall initiated by company
9 Dec 2014	Classified by FDA	+28 days
17 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay