Quality & complianceOfficial

Siemens Healthineers recalls MAGNETOM Flow.Ace software over cardiac flow quantification issue, Health Canada reports

🇨🇦 Health Canada · Thu 05 Nov 2026

Health Canada has posted a Type II recall covering a syngo.via MR Flow Quantification issue when Beat Sensor triggering is used for retrospectively gated 2D cardiac flow scans on the MRI system.

Health Canada published a recall notice on 5 November 2026 for the MAGNETOM Flow.Ace MRI scanner, made by Siemens Shenzhen Magnetic Resonance Ltd. The agency classes the problem as a medical device performance issue and lists the recall date as 26 October 2026 under identification number RA-82919.

According to the notice, Siemens Healthineers is advising customers of a software issue affecting syngo.via MR Cardiac Analysis MR Flow Quantification. The issue arises when the software is used with Beat Sensor triggering for retrospectively gated 2D cardiac flow examinations. The notice does not describe the nature of the fault or any consequences for patients or image results.

The recall applies to MAGNETOM Flow.Ace systems running one of several Numaris/X software versions: VA51A, VA60A, VA61A, VA70A, VB10A, or VB20A/NX2510. Affected systems must also hold both the Beat Sensor / Pilot Tone Cardiac License (11344791) and the syngo.via MR Cardiac Analysis MR Flow Quantification License (7106227 or 11344838).

The listing gives one affected product entry, with the identifier 218718 and the model or catalogue number 11571247. The audience is healthcare, and the only action advised is to contact the manufacturer for further information. Under Health Canada's system, a Type II recall generally involves products that may cause temporary or medically reversible health effects, or where serious harm is unlikely.

What it means for your team

  • Manufacturers and regulatory teams with MAGNETOM Flow.Ace systems in Canada should check software versions and installed licences against the criteria in the notice.
  • Quality and field-safety teams should contact Siemens Healthineers for details, as the Health Canada listing does not set out the cause, the clinical impact or any corrective steps.
  • Teams tracking global field actions may wish to check whether equivalent notices have been issued in other markets, since the source covers Canada only.

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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