FDA-Device2016-06-15Class II
Sedecal SA Mobile Diagnost w DR x-ray system
Sedecal USA, Inc.
Hazard
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.
Sold states
US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.
Affected count
US - 145
Manufactured in
230 Lexington Dr, N/A, Buffalo Grove, IL, United States
Products
Sedecal SA Mobile Diagnost w DR x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2016Don't want to check this manually?
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