Official recall record

Siemens Healthineers AG Magnetom and Biograph One Systems

What the authority reported

A software issue has been identified in syngo.via MR Cardiac Analysis MR Flow Quantification affecting the evaluation of retrospectively gated 2D cardiac flow data. The algorithm does not correctly represent the final phase of the cardiac cycle. The evaluation stops at the last trigger time point (TT point), which marks the beginning of the final cardiac phase, instead of accounting for the complete duration of that phase until the end of the cardiac cycle. The final repetition-time interval (TR) is not included in the calculation (“TR missing”). This results in systematic truncation of the cardiac cycle and incomplete loop closure. Consequently, flow quantification parameters (e.g., Forward volume, Avg.Flow/Min) are systematically underestimated. The impact is relevant for Beat Sensor-triggered flow data, for which the flow peak occurs in the very last acquired cardiac phases.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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