Reported Aug 21, 2013 · Terminated

Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological 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 SW version VA20 with Mammography license. image processing, radiological system
Lot codes and dates
    • Model number 10592457
    • serial numbers 100219
    • 100201
    • 100473. Update dated 5/13/13 included
  • the following additional serial numbers
    • 100177
    • 100504
    • 100174
    • 100181
    • 100473
    • and 100539
Amount recalled
6

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

Why it was recalled

Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

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 Mar 9, 2015 · Data as of Sep 19, 5:31 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.