Siemens Healthineers MRI software fix reaches seven Canadian scanners under Health Canada recall
A Type II recall of the MAGNETOM Flow.Elite software touches a small set of serial numbers, and the notice gives no cost, sales or incident data.
Siemens Healthineers is rolling out a software hotfix for its MAGNETOM Flow.Elite MRI system in Canada. Health Canada posted the recall on 12 November 2026 under reference RA-82946. The notice carries a recall date of 29 October 2026, about two weeks before publication, and is classed as a performance issue.
The commercial footprint looks narrow. Seven serial numbers are listed: 234818, 234821, 234825, 234826, 234827, 234832 and 234851. Each appears under two catalogue numbers, 11851911 and 11878345. The affected machines run software version VB20A-2510. The notice does not say how many units are in service, and it gives no cost estimate, revenue figure or figure for sales in Canada.
The remedy is syngo MR XB20A-HF02 (NX2510-WSMW), a bug-fix update that is added on top of the existing installation rather than replacing it. It addresses how the system detects BioMatrix Head/Neck Pro Coil elements on Tim[108x24] and Tim[108x48] configurations. It also improves error logging, system stability during and after start-up, and the reliability of the patient table.
Health Canada lists healthcare professionals as the audience and tells them only to ask the manufacturer for more details. The notice does not say how the faults were found, and it reports no patient harm or incidents. As general context, a Type II classification covers products that may cause temporary or medically reversible effects, or where serious harm is considered unlikely. The notice does not say whether comparable actions are under way in other markets.
Why it matters
- The exposure in Canada is limited to seven listed serial numbers, so any financial effect on Siemens Healthineers from this action cannot be gauged from the notice.
- A software-only remedy, with no hardware replacement mentioned, points to a lighter service burden, though the notice itself gives no cost or scheduling detail.
- With no cause, incident data or unit count disclosed, the notice offers little basis for judging risk. Further detail would have to come from the manufacturer.
- The notice says nothing on whether other regulators have issued similar actions for the same software version.
Official record: Health Canada ↗
Written by CompePharma's editorial system from the official record. AI-assisted; check the source before acting. Not investment advice.