Loading...
Loading...
A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.