MEDRAD STELLANT FLEX CT INJECTION SYSTEM

Description of Event or Problem

MEDRAD STALLANT FLEX HAS RELEASED AN UPDATED SOFTWARE VERSION, THAT FIXES THE SOFTWARE BUG AND ISSUE WHEN THE USER INSTALLS OR INSERTS THE TWO SYRINGES AT THE SAME TIME, AFTER A CERTAIN AMOUNT OF TIME THE BOARD WILL TIME UP AND GIVE ERROR CODE 2107 AND VERIFY THIS ERROR ALSO INSERT THE TWO SYRINGES BOTH AT THE SAME TIME WITHOUT LEAVING 5-SECOND GAP BETWEEN BOTH AND ANOTHER ERROR 2116 IS APPEARING, MEDARD SHOULD ANNOUNCE THE RECALL AND INSTALL ALL THE SOFTWARE UPDATES FOR FREE BECAUSE OF THEIR DEFECTIVE PATCH, BUT NOT CHARGE CUSTOMERS FOR THE ISO IMAGE ASSOCIATED WITH THE SOFTWARE UPDATE. SINCE THE PROBLEM IS NOT A USER ERROR BUT IS MANUFACTURER DEFECT. ATTACHED IS THE FSR WITH (B)(6) DOLLARS FOR A CHARGE THAT IS NOT A USER ISSUE AND IT IS A DEFECTIVE MANUFACTURER ERROR ON ALL THE FLEX MODELS IN THE STATES. KINDLY I HOPE THAT THE FDA CAN REVIEW AND INVESTIGATE THIS CASE AND THE ISSUE WITH ALL CT SITES THAT CARRY THE SAME MODEL AND ENCOUNTER THE MENTIONED ERROR, CAUSING A PROBLEM THAT ENDS UP TO REBOOT THE DEVICE AFTER.