| Reason for the Action |
A defect was identified following the release of Salix Coronary Plaque (SCP) v1.2 in Australia, where clinicians observed that MESA percentiles were no longer being automatically generated for some patients where ethnicity information was not available.
Investigation determined that SCP v1.2 had corrected the handling of missing ethnicity values by removing the historical default ethnicity assignment. As part of the investigation, other commercially distributed software variants were reviewed, and it was identified that Salix (AU), prior to SCP v1.2, contained a defect whereby the MESA percentile calculation defaulted ethnicity to Caucasian when no ethnicity was specified. This default value was applied in the background and was not visible to the user.
An incorrect MESA percentile was presented to clinicians due to this software defect. This may have resulted in the patient's coronary calcium burden being represented inaccurately relative to the reference population.
No adverse events, serious injuries, or deaths associated with this problem have been reported. |