Sedecal USA, Inc. recalls Sedecal SA Mobile Diagnost w DR x-ray system

Recall date

March 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1691-2016

FDA classification

Class II

Brand / firm

Sedecal USA, Inc.

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sedecal SA Mobile Diagnost w DR x-ray system