Cardiac Flow Software Error Prompts Siemens Magnetom, Biograph One Recall 2026

A software flaw in Siemens Healthineers imaging systems can make cardiac blood flow measurements read lower than they really are. Health Canada has published a Type II recall for a range of Magnetom and Biograph One systems made by Siemens Healthineers AG, after the company found that its cardiac flow analysis software does not count the full heartbeat cycle.

The notice was published on 2026-10-28 under recall number RA-82872. The recall date is listed as 2026-10-20. The audience is healthcare, which means hospitals, imaging centres and clinicians, not the general public.

Products Affected by This Recall

The recall covers several Magnetom MRI models and the Biograph One system. Health Canada lists the following models and catalogue numbers:

• Magnetom Sola (model 11291455): more than 10 serial numbers, contact the manufacturer
• Magnetom Sola Fit (model 11410482): more than 10 serial numbers, contact the manufacturer
• Magnetom Flow.Elite (model 11851911): serial numbers 234786, 234723, 234827 and 234832
• Magnetom Lumina (model 11344916): serial number 196680
• Biograph One (model 11689172): serial numbers 238015 and 238023
• Magnetom Vida Fit (model 11410481): serial numbers 202203 and 202080
• Magnetom Vida (model 11060815): more than 10 serial numbers, contact the manufacturer
• Magnetom Viato.Mobile (model 11689652): serial number 239040

The notice does not give the number of units affected. For the Sola, Sola Fit and Vida models, the full serial number lists are too long to print on the notice, so facilities must ask Siemens for them.

What Went Wrong?

The problem sits in syngo.via MR Cardiac Analysis, in the MR Flow Quantification function. This function evaluates retrospectively gated 2D cardiac flow data, which is used to measure how blood moves through the heart and vessels during a heartbeat.

According to the notice, 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 beginning of the final cardiac phase. It does not carry on to the end of the cycle. The final repetition-time interval is left out of the calculation, which the notice describes as ‘TR missing’.

The result is a systematic truncation of the cardiac cycle and an incomplete loop closure. Flow quantification parameters, including Forward volume and Avg.Flow/Min, are therefore systematically underestimated.

The notice says the impact is relevant for Beat Sensor-triggered flow data, where the flow peak occurs in the very last acquired cardiac phases. In those cases the part of the cycle that is cut off is the part that matters most for the measurement.

Who Should Be Concerned

This is a Health Canada notice aimed at healthcare audiences. It is relevant to any Canadian facility that operates one of the listed systems and uses the syngo.via MR Flow Quantification function. It matters most for sites that analyse Beat Sensor-triggered cardiac flow data.

Patients are not asked to take any action themselves. Anyone who has had a cardiac MRI and has questions about how their flow results were calculated should speak to the clinician or imaging department that handled the scan.

Steps Consumers Should Take

The only instruction in the notice is short: contact the manufacturer if you require additional information. Facilities that run the listed systems should consider the following practical steps:

• Check the model and serial numbers of installed systems against the list above.
• For the Sola, Sola Fit and Vida models, ask Siemens Healthineers for the full serial number lists.
• Identify any cardiac flow studies that used Beat Sensor triggering and were analysed with this function.
• Ask Siemens Healthineers for guidance on how the results should be interpreted.

The notice does not describe a software fix, a replacement or a timeline for correction. Facilities should confirm those details directly with the manufacturer.

Regulatory Response

Health Canada classified the action as a Type II recall under the category of medical devices in radiology. The issue is listed as a medical device performance problem. The company named on the notice is Siemens Healthineers AG, based in Forchheim, Germany.

The listing was published by Health Canada’s Medical devices program and last updated on 2026-10-28. The agency also invites the public to report health or safety concerns through its online reporting service, and to subscribe for email updates on new recalls and safety alerts.

Quick Facts

• Recall number: RA-82872
• Recall class: Type II
• Recall date: 2026-10-20
• Published: 2026-10-28
• Issue: Medical devices – Performance
• Software involved: syngo.via MR Cardiac Analysis, MR Flow Quantification

This article is based on the official Health Canada recall notice. Readers with a technical or clinical question should contact Siemens Healthineers AG directly.