Description of Event or Problem · 0
EXO IMAGING ASKED COMMERCIAL TEAM TO DEMONSTRATE THE IRIS APP ON IOS IN THE TEST, (BETA) APP, DEMONSTRATING AI FEATURES THAT WERE NOT FDA APPROVED, SUCH AS CARDIAC AI, LUNG AI, AND HIP AI, TO PHYSICIANS, NOT TO UPDATE IOS SOFTWARE TO THE CURRENT UPDATED IOS OPERATING PLATFORM. NOT TO PROVIDE ANY CONTRADICTIONS ABOUT PRODUCT TO CUSTOMERS, SUCH AS CARDIAC ARRHYTHMIAS, DEMONSTRATING PRODUCT IN CARE AREAS WHERE DEVICE NOT APPROVED SUCH AS NICU. DEMONSTRATING PRODUCT ON HELICOPTERS AND AMBULANCES WITHOUT THE PRIOR CERTIFICATES. USING ENCRYPTED COMMUNICATION SUCH AS SIGNAL TO COMMUNICATE ABOUT PRODUCT. NOT ADDRESSING THE PRODUCT WAS HAVING REPEAT FAILURES OF DEVICE OVERHEATING WITHIN LESS THAN 5 MINUTES OF SCANNING. THE PULSED WAVE DOPPLER SPECTRAL WAVEFORM, COLOR FLOW WAS NOT ACCURATE, DEMONSTRATING MEDICAL INACCURATE DOPPLER READINGS AND EJECTION FRACTION CARDIAC VALUES AND B LINES ON AI LUNG EXAM TYPE. SHARING LOGS AND FINDINGS TO UPPER MANAGEMENT AND COMPLIANCE WITHOUT ANY SHARING TO TEAM OR INVESTIGATION. PROVIDING CUSTOMERS WHO BOUGHT DEVICE IPHONES AT NO COST FOR THE PRODUCT TO WORK. NOT USING THE SAME CHARGING STYLE OF TETHERED CORD, OUTSOURCING TO DIFFERENT COUNTRIES. OFFERING CUSTOMERS IF THEY BUY 50, THEY GET X AMOUNT AT NO COST. PAYING CUSTOMERS TO SHARE POSITIVE INFORMATION ONLINE TO TRY TO INCREASE REVENUE. USING PHILLIPS NORTH AMERICA AND GE ULTRASOUND IMAGES AS THEIR OWN. CONNECTING ALL THE EXO IRIS DEVICES TO EMR/PACS/ EXO WORKS ENTERPRISE TO BILL AND CHARGE MEDICARE, MEDICAID, AND PRIVATE INSURANCE COMPANIES.