Reported Feb 12, 2014 · Terminated

Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed,…

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 SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Lot codes and dates
    • models 8098027
    • 7740769
    • 10430603
    • 10590000
  • with multiple serial numbers

    147 of 147 codes

    • 64789
    • 64492
    • 66767
    • 66649
    • 64067
    • 66182
    • 65364
    • 64673
    • 64419
    • 66518
    • 66243
    • 64368
    • 64081
    • 60398
    • 66929
    • 66327
    • 66146
    • 66188
    • 66355
    • 66467
    • 64860
    • 64342
    • 73579
    • 73813
    • 64179
    • 66498
    • 64172
    • 66433
    • 66572
    • 66768
    • 64790
    • 66193
    • 64270
    • 66503
    • 65013
    • 65014
    • 64821
    • 64337
    • 64734
    • 65036
    • 66455
    • 66451
    • 66928
    • 65403
    • 65597
    • 64770
    • 66964
    • 66924
    • 64082
    • 66151
    • 66911
    • 65576
    • 67017
    • 64481
    • 64694
    • 66844
    • 73366
    • 64430
    • 65302
    • 64624
Amount recalled
147

Where it was sold

  • Nationwide

Why it was recalled

During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

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

Want the full recall guide?

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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 10, 2015 · Data as of Sep 19, 6:16 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.