Health Canada alert flags Siemens cardiac flow software error

A software issue in Siemens Healthineers AG's syngo.via MR Cardiac Analysis MR Flow Quantification causes the algorithm to misrepresent the final phase of the cardiac cycle, Health Canada said in a recall and safety alert published Oct. 28. The evaluation stops at the last trigger time point, which marks the beginning of the final cardiac phase, rather than accounting for that phase through to the end of the cardiac cycle.¹

The alert says the final repetition-time interval, the gap between successive measurements in the scan, is left out of the calculation, a fault it describes as "TR missing." The result is systematic truncation of the cardiac cycle and incomplete loop closure, and flow quantification parameters such as Forward volume and Avg.Flow/Min are systematically underestimated.¹

The regulator says the impact is relevant for Beat Sensor-triggered flow data, where the flow peak occurs in the very last acquired cardiac phases. The alert names the Magnetom and Biograph One systems.¹