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Siemens MRI software fix reaches just two Canadian scanners, Health Canada notice shows

A hotfix for the MAGNETOM Flow.Elite covers only two installed systems in Canada, limiting the recall's footprint, though the notice offers no cost or incident data.

12 Nov 2026 · Health Canada · Regulator

The commercial exposure from a newly listed Siemens Healthcare MRI recall in Canada looks small. Health Canada's notice, RA-82938, names two affected scanners of the MAGNETOM Flow.Elite model, with serial numbers 234787 and 234789. Both run software VB10B-2510 and share catalogue number 11851911.

The regulator posted the entry on 12 November 2026 and gives 29 October 2026 as the recall date. It files the action as a medical device performance issue. The remedy is a software hotfix, syngo MR XB10B-HF02 (NX2510-WSMW), applied as an incremental update rather than a full reinstall of the system software.

The notice lists four areas of change. The hotfix corrects how the system detects BioMatrix Head/Neck Pro Coil elements in Tim[108x24] and Tim[108x48] configurations. It also improves data logging so error cases are easier to spot, makes the system steadier during and after start-up, and makes the patient table more stable and reliable.

The entry does not describe specific failures, incidents or injuries, and it puts no figure on the cost of the correction or on any downtime for the two sites. Siemens Healthcare GmbH of Erlangen, Germany, is listed as manufacturer, and the audience is healthcare. By way of context, Health Canada's Type II category generally covers recalls where use of a product may cause temporary or medically reversible adverse effects, or where the chance of serious harm is remote.

Why it matters

  • Only two Canadian units are listed, so the notice points to a narrow commercial and service impact in this market.
  • The fix is a software update rather than a hardware change, and the notice discloses no cost or downtime figures.
  • With no incident data published, the notice offers little on the severity of the underlying problems beyond the regulator's classification.

Official record: Health Canada ↗

Written by CompePharma's editorial system from the official record. AI-assisted; check the source before acting. Not investment advice.

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