RegulatoryOfficial

Siemens Healthineers MR and PET/MR systems recalled in Canada over cardiac flow software error

🇨🇦 Health Canada · Wed 28 Oct 2026

Health Canada reports a syngo.via MR Flow Quantification issue that truncates the final cardiac phase and systematically underestimates flow parameters in retrospectively gated 2D data.

Health Canada has published a Class II recall covering Siemens Healthineers AG Magnetom and Biograph One systems, citing a software performance issue in the syngo.via MR Cardiac Analysis MR Flow Quantification application. The recall date is 20 October 2026, and the notice was published on 28 October under identification number RA-82872.

According to the notice, the problem affects 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, which marks the start of that phase, rather than covering its full duration to the end of the cycle. The final repetition-time interval is therefore left out of the calculation, described in the notice as "TR missing".

Health Canada says this systematically truncates the cardiac cycle and leaves the loop incompletely closed. As a result, flow quantification parameters, such as forward volume and average flow per minute, are systematically underestimated. The impact is described as relevant for Beat Sensor-triggered flow data, where the flow peak falls in the very last acquired cardiac phases.

The affected products include several Magnetom models (Sola, Sola Fit, Flow.Elite, Lumina, Vida Fit, Vida and Viato.Mobile) and Biograph One, listed with serial and model numbers. For Magnetom Sola, Sola Fit and Vida, the notice lists more than 10 serial numbers and refers users to the manufacturer. The only action given is to contact the manufacturer for further information. The notice is aimed at healthcare audiences, and the manufacturer is based in Forchheim, Germany.

As general context, a Class II recall in Health Canada's system generally relates to products that may cause temporary or medically reversible adverse effects, or where serious harm is considered unlikely.

What it means for your team

  • Teams with affected Siemens MR or Biograph One systems should check serial numbers against the notice and contact the manufacturer, as the full list for some models is not published.
  • Quality and clinical engineering functions may want to establish whether Beat Sensor-triggered, retrospectively gated 2D flow studies were evaluated with the affected software, since the underestimation is systematic.
  • Regulatory and vigilance teams should note the recall as a software performance issue and check whether equivalent field safety actions apply in other markets; the notice does not say.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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