Reported Dec 17, 2014 · Terminated

Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355-1406

Is this the product you have?

  • Syngo.plaza, Syngo.plaza VB10A
  • and syngo Imaging XSProduct
  • UsageSyngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images
Lot codes and dates
  • model numbers
    • 10592457
    • 10863171
    • 10863172
    • 10863173
    • 7502029
    • 10496279
  • with multiple serial numbers

    149 of 149 codes

    • 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
Amount recalled
149

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 24, 2015 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.