Z-1691-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2016
- Initiation Date
- March 23, 2015
- Termination Date
- March 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US - 145
Product Description
Sedecal SA Mobile Diagnost w DR x-ray system
Reason for Recall
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.
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.
Code Information
System Code 712001