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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 Healthineers is issuing a delta-installation hotfix, XB20A-HF02, for seven MAGNETOM Flow.Elite scanners in Canada, addressing coil detection, logging, start-up stability and patient table reliability.

Health Canada published a health product recall on 12 November 2026 for the MAGNETOM Flow.Elite MR system from Siemens Healthineers AG. The notice, identification number RA-82946, covers a performance issue and carries a recall date of 29 October 2026.

The fix is hotfix syngo MR XB20A-HF02 (NX2510-WSMW), described as a bug fix update installed as a delta installation. It 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, general system stability during and after start-up, and the stability and reliability of the patient table.

The affected units run software VB20A-2510 and are identified by serial numbers 234818, 234821, 234825, 234826, 234827, 234832 and 234851. Each serial number is listed under two catalogue numbers, 11851911 and 11878345. The notice does not say how many units are in use or explain how the problems were found.

Health Canada classes the recall as Type II and lists healthcare professionals as the audience. The only instruction given is to contact the manufacturer for additional information. As general context, a Type II recall concerns products that may cause temporary or medically reversible health effects, or where serious harm is considered remote.

What it means for your team

  • Sites operating MAGNETOM Flow.Elite systems should check their serial numbers against the seven listed and contact Siemens Healthineers for details on the hotfix.
  • Regulatory and quality teams should record the recall under RA-82946, with the recall date of 29 October 2026, and check whether similar field actions apply in other markets.
  • The notice gives no information on patient harm or incident reports, so any risk assessment will need information from 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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