FDAFDA · Food and drugs·Recall number Z-0576-2015
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.
Published December 17, 2014 · Recall initiated: November 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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