SYNGO DYNAMICS

Description of Event or Problem

A CUSTOMER SITE REPORTED THAT THE V MAX VALUE WAS INCORRECT WHEN USING THE SYSTEM'S CARDIAC CALCULATION FEATURE FOR SPECIFIC VTI MEASUREMENTS (AORTIC VALVE VELOCITY-TIME INTEGRAL). THE SYSTEM'S DERIVED V MAX WAS LOWER THAN EXPECTED. CONSEQUENTLY THE MEASUREMENTS IMPORTED INTO WORKSHEETS AND REPORTS WERE INCORRECT. THE FACTORY WAS ABLE TO REPRODUCE THIS REPORTED ISSUE. ALTHOUGH WE ARE UNAWARE OF ANY PT INJURY ASSOCIATED WITH THIS ISSUE, THIS PROBLEM HAS THE POTENTIAL TO AFFECT A PHYSICIAN'S DIAGNOSTIC DECISIONS IF IT RECURS. A CUSTOMER SAFETY ADVISORY NOTICE WAS CREATED AND WILL BE DISTRIBUTED TO ALL AFFECTED CUSTOMERS. FURTHERON A SOFTWARE PATCH WILL BE MADE AVAILABLE FOR UPGRADE OF THE SOFTWARE VERSION.