Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sedecal SA Mobile Diagnost w DR x-ray system Recalled by Sedecal USA, Inc. Due to Due to a software defect, the system may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sedecal USA, Inc. directly.
Affected Products
Sedecal SA Mobile Diagnost w DR x-ray system
Quantity: US - 145
Why Was This 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.
Where Was This Sold?
This product was distributed to 30 states: AZ, AR, CA, CT, DE, FL, GA, HI, ID, IN, IA, KS, LA, ME, MD, MA, MI, MN, NH, NJ, NY, NC, OH, PA, TN, TX, UT, VT, WA, WI
About Sedecal USA, Inc.
Sedecal USA, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report