Device product
Sedecal SA Mobile Diagnost w DR x-ray system
Z-1691-2016
Product summary
- Event
- Event 74106
- Status
- Terminated
- Classification
- Class II
- Quantity
- US - 145
- Official record key
device-enforcement:Z-1691-2016
Official wording
Reason: 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.
Code information: System Code 712001
Distribution pattern: 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.
Derived failure modes
-
Device software or design
software defect