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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69802

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 11, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0576-2015
Recall number
Z-0576-2015
Initiated
November 11, 2014
Classification
Class II
Status
Terminated
Quantity
149

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

US Nationwide Distribution