Reported Sep 11, 2019 · Terminated
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition…
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 · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- syngo.CT software version VA48A_SP5.5 in the following
- SOMATOM computed tomography models
SOMATOM Definition Edge-Model #10590000SOMATOM Definition AS Model #8098027SOMATOM Definition Flash Model #10430603
- Lot codes and dates
- syngo.CT software version VA48A_SP5.5
- Amount recalled
- 2867 units worldwide (OUS); 1464 units US
Where it was sold
- Nationwide
Why it was recalled
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
This product could cause temporary or reversible health problems — stop using it.
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