| Reason for the Action |
A software problem has been identified in Atrio v5.0.1 and Atrio Plus v1.1.0-2.0.0 versions that may cause certain automated rhythm-related Holter report statistics to be inaccurate after Full Recording Analysis. The problem may affect selected rhythm statistics, including sinus bradycardia, sinus tachycardia, atrial run, pause, atrial bigeminy, atrial trigeminy, and related rhythm values.
The problem may result in some rhythm findings being overrepresented in reports. It is not expected to cause missed identification of affected arrhythmias. Beat-level annotations, heart rates, heart rate variability, ECG waveform data, manually added annotations, and initial AI analysis are not affected.
The potential impact is that a clinician may review a report containing inaccurate rhythm-based statistics, which could lead to unnecessary follow-up, monitoring, investigation, referral, or treatment. No adverse events, serious injuries, deaths, or confirmed patient harm have been identified to date. |