Reported Aug 1, 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
Amount recalled
2

Where it was sold

Why it was recalled

Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

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 Jan 14, 2014 · Data as of Sep 19, 5:26 PM UTC

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