Reported Sep 21, 2016 · Terminated

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate,…

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 · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Lot codes and dates
  • Model Numbers
    • 10863171
    • 10863172
    • 10863173
    • 10592457
  • Serial Numbers

    99 of 99 codes

    • 100262
    • 100389
    • 100198
    • 100258
    • 100259
    • 100538
    • 100135
    • 100133
    • 100213
    • 100214
    • 100031
    • 100032
    • 100484
    • 100362
    • 100233
    • 100140
    • 100141
    • 100142
    • 100143
    • 100144
    • 100416
    • 100105
    • 100106
    • 100109
    • 100110
    • 100111
    • 100112
    • 100113
    • 100114
    • 100115
    • 100116
    • 100117
    • 100119
    • 100120
    • 100461
    • 100457
    • 100245
    • 100447
    • 100364
    • 100314
    • 100298
    • 100299
    • 100386
    • 200277
    • 100139
    • 100027
    • 100028
    • 100300
    • 100559
    • 100440
    • 100441
    • 100197
    • 100170
    • 100025
    • 100026
    • 100084
    • 100186
    • 100189
    • 100190
    • 100191
Amount recalled
101 Systems

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

Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.

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 Mar 20, 2017 · Data as of Sep 19, 5:20 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.