Quality & complianceOfficial

Health Canada lists Class II recall of Siemens Healthineers Magnetom MRI scanners over software service pack

🇨🇦 Health Canada · Wed 28 Oct 2026

Siemens Healthineers is rolling out service pack NX VA60A-SP04, a full-installation bug fix, for Magnetom scanners under a Type II recall recorded by Health Canada.

Health Canada has published a Type II recall for Magnetom scanners made by Siemens Healthineers AG, listed under identification number RA-82871. The recall date is 20 October 2026 and the notice was published and last updated on 28 October 2026. The issue is categorised as a medical device performance problem in the radiology category.

The remedy is service pack NX VA60A-SP04, described as a bug fix update delivered as a full installation. It includes the latest IT security deliveries and an overall stability increase, with syngo MR XA60A-SD12 content included. It also allows several software delta packages to be installed at the same time.

The notice says the update implements EU Data Act (Regulation (EU) 2023/2854), giving access to all machine data. It fixes image loading errors for MR Breast Biopsy and brings improvements to the General MR Protocol Manager. Coil specifications are adjusted for the BM Body 18 Pilot Tone and Spine 32 coils, and image brightness is addressed for 1.5T Sentinelle Breast coils.

The package also supports IEC 60601-1 compliance, which the notice says enables predictable and safe system behaviour with regard to table movement. Affected products are listed as Magnetom Scanner, with model or catalogue numbers 11060815, 11344916 and others. The notice lists serial or lot numbers 196408, 196427, 196822, 196406 and 196680, and says that for more than 10 numbers users should contact the manufacturer. The advice is to contact the manufacturer for additional information. Siemens Healthineers is based at Siemensstr. 3, Forchheim, Germany.

For context, a Type II recall in Health Canada's system generally covers products that may cause temporary or medically reversible adverse effects, or where serious harm is considered unlikely.

What it means for your team

  • Sites operating Magnetom systems should check their serial numbers against the notice and contact Siemens Healthineers where the list is truncated.
  • Quality and regulatory teams should record the service pack installation and the Type II classification (RA-82871) in field-action and CAPA files.
  • The inclusion of EU Data Act data-access functionality and IEC 60601-1 table-movement behaviour shows software updates being used to deliver compliance changes alongside bug fixes.
  • Imaging departments using the named coils or MR Breast Biopsy workflows should note the specific fixes when planning installation.

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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