Siemens Healthineers MRI software recall in Canada centres on cardiac flow scans

Siemens Healthineers has started a field action in Canada on software for its MAGNETOM Flow.Ace magnetic resonance scanner, according to a notice Health Canada published on 5 November 2026. The company's own recall date is given as 26 October 2026, and the regulator logged it under reference RA-82919. The notice does not say how many scanners are involved or what the action will cost, so any commercial effect on the company cannot be gauged from it.

The problem concerns the syngo.via MR Cardiac Analysis tool that quantifies blood flow. It arises when Beat Sensor triggering is used for retrospectively gated two-dimensional cardiac flow examinations. The scanner is listed as manufactured by Siemens Shenzhen Magnetic Resonance Ltd. Health Canada classifies the matter as a device performance issue but does not describe what goes wrong or whether images or measurements are affected.

Scope is defined by configuration. Affected systems run one of six Numaris/X releases: VA51A, VA60A, VA61A, VA70A, VB10A or VB20A/NX2510. They must also carry both the Beat Sensor / Pilot Tone Cardiac licence (11344791) and a flow quantification licence (7106227 or 11344838). The listing contains a single product entry, identifier 218718, catalogue number 11571247. It is aimed at healthcare users, who are told only to contact the manufacturer.

By way of context, Health Canada's Type II category generally covers products that may cause temporary or medically reversible health effects, or where serious harm is considered unlikely. The notice covers Canada only, and it does not say whether comparable actions exist elsewhere.