Reported Jun 15, 2016 · Terminated
Sedecal SA Mobile Diagnost w DR x-ray system
Sedecal 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: Sedecal USA, Inc. · 230 Lexington Dr · Buffalo Grove, IL · 60089-6930
Is this the product you have?
- Sedecal SA Mobile Diagnost w DR x-ray system
- Lot codes and dates
- System Code 712001
- Amount recalled
- US - 145
Where it was sold
Why it was recalled
Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.
This product could cause temporary or reversible health problems — stop using it.
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