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Sedecal USA, Inc. recalls Sedecal SA Mobile Diagnost w DR x-ray system
Recalled June 15, 2016 · FDA recall Z-1691-2016 · Sedecal USA
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. · FDA Class II
Units
US - 145
Sold at
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.
Description
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.
Product
Sedecal SA Mobile Diagnost w DR x-ray system
Manufacturer(s)
Sedecal USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →