Reported Feb 4, 2015 · Terminated

Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read,…

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
  • plazaSyngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
Lot codes and dates
  • Model Numbers
    • 10592457
    • 10863171
    • 10863173
    • 10863172
  • with serial numbersSerial
    • 100544
    • 100262
    • 100198
    • 100258
    • 200211
    • 100135
    • 100133
    • 100213
    • 100031
    • 100084
    • 100233
    • 100140
    • 200308
    • 100245
    • 100314
    • 100139
    • 100177
    • 100197
    • 100170
    • 100025
    • 100174
    • 100186
    • 100033
    • 100306
    • 100232
    • 100185
    • 100256
    • 100199
    • 100188
    • 100257
    • 100198
    • 100226
    • 100198
    • 100228
    • 100181
    • 100029
    • 100253
    • 100301
    • 100203
    • 100132
    • 100139
    • 100247
    • 100215
    • 100230
    • 100221
    • 100146
    • 100207
    • 100212
    • 100539
    • 100206
Amount recalled
50

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

In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.

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 16, 2017 · Data as of Sep 19, 4:44 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.