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Health Canada lists Type II recall of Siemens MAGNETOM Flow.Elite MRI software hotfix

🇨🇦 Health Canada · Thu 12 Nov 2026

Siemens Healthcare's syngo MR XB10B-HF02 hotfix, covering two MAGNETOM Flow.Elite systems in Canada, addresses coil detection, data logging, start-up stability and patient table reliability.

Health Canada has published a Type II recall for the Siemens MAGNETOM Flow.Elite magnetic resonance system, citing a medical device performance issue. The notice, identification number RA-82938, was posted on 12 November 2026. The recall date is given as 29 October 2026.

The corrective measure is Hotfix syngo MR XB10B-HF02 (NX2510-WSMW), described as a bug fix update installed as a delta installation. Only two units are listed as affected: serial numbers 234787 and 234789, both running software VB10B-2510 under catalogue number 11851911.

According to the notice, the hotfix corrects detection of BioMatrix Head/Neck Pro Coil elements on system configurations with Tim[108x24] and Tim[108x48]. It also improves data logging to help detect error cases, and improves general system stability during and after start-up. A further change improves the stability and reliability of the patient table.

The notice gives no further detail on specific failures, incidents or injuries, and it says only that users should contact the manufacturer if they need more information. The listed manufacturer is Siemens Healthcare GmbH of Erlangen, Germany, and the audience is healthcare. As general context, Health Canada's Type II classification generally applies to recalls where use of the product may cause temporary or medically reversible adverse effects, or where the likelihood of serious harm is remote.

What it means for your team

  • Sites in Canada operating MAGNETOM Flow.Elite units should check whether their serial numbers match 234787 or 234789 with software VB10B-2510.
  • Quality teams should confirm with Siemens how and when the XB10B-HF02 delta installation is being applied and keep a record of completion.
  • Regulatory and vigilance staff should note that the notice gives no incident data, so any questions on the underlying issues should go to the manufacturer.

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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