Reported Oct 17, 2012 · Terminated

Siemens syngo.plaza radiological image processing system.

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

Is this the product you have?

  • Siemens syngo.plaza radiological image processing system.
Lot codes and dates
    • Model number 10592457
    • serial numbers 100263
    • 100401
    • 100177
    • 100138
    • 100174
    • 100406
    • 100249
    • 100201
    • 100198
    • 100181
    • 100146
Amount recalled
11

Where it was sold

Why it was recalled

Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 13, 2013 · Data as of Sep 19, 6:51 PM UTC

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