Medications & Supplements Medium Severity Voluntary

Health Canada Posts Type II Recall of Siemens Magnetom Free.Max 2026

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Health Canada has listed a Type II health product recall for the Magnetom Free.Max, a radiology device made by Siemens Shenzhen Magnetic Resonance Ltd. The recall carries identification number RA-82867 and a recall date of October 20, 2026. The notice was published and last updated on the Government of Canada recalls site on October 27, 2026.

The alert is addressed to a healthcare audience, not to the general public. The issue is classified as a medical device performance matter, and the manufacturer points to a software service pack as the corrective package.

  • Product: Magnetom Free.Max
  • Manufacturer: Siemens Shenzhen Magnetic Resonance Ltd.
  • Recall class: Type II
  • Recall number: RA-82867
  • Recall date: 2026-10-20
  • Lot or serial number: 206217

Products Affected by This Recall

The notice names a single product, the Magnetom Free.Max, under two model or catalogue numbers. Both entries share the same lot or serial number.

  • Magnetom Free.Max, model or catalogue number 11408425, lot or serial number 206217
  • Magnetom Free.Max, model or catalogue number 11408424, lot or serial number 206217

The notice does not state how many units are involved. It also does not give a UPC or list specific Canadian provinces or facilities. Healthcare providers that operate this system should check the lot or serial number and model number against the table above.

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What Triggered the Recall

The official notice describes the issue as a medical device performance matter. It explains the corrective action in terms of a software update, the service pack NX VA60A-SP04. The notice describes this as a bug fix update with a full installation.

According to the notice, the service pack solves or improves the following:

  • The latest IT security deliveries and an increase in overall stability, with syngo MR XA60A-SD12 content included
  • Installation of multiple software delta packages at the same time
  • Implementation of EU Data Act (EU) 2023/2854, giving access to all machine data
  • Image loading errors for MR Breast Biopsy
  • General improvements to the MR Protocol Manager
  • Adjusted coil specifications for the BM Body 18 Pilot Tone and Spine 32 coils, and for image brightness on the 1.5T Sentinelle Breast coils
  • Support for IEC 60601-1 compliance, enabling predictable and safe system behavior with regard to table movement

Several of these items concern software stability, security and image handling. The last item refers to predictable and safe system behavior regarding table movement. The notice does not describe any injury, adverse event or patient harm linked to the device, and it does not say how the listed items relate to one another.

Who Should Be Concerned

The notice lists its audience as healthcare. That points to hospitals, imaging centres and clinical staff responsible for the equipment, rather than patients or ordinary consumers. The product falls under the Health products, Medical devices and Radiology category on the Health Canada site.

Siemens Shenzhen Magnetic Resonance Ltd. is listed at the Siemens MRI Center in Shenzhen, China, postal code 518057. Health Canada is the publishing authority for the notice.

A Type II recall classification is the category assigned on the Health Canada listing for this action. The notice itself does not add further explanation of the class, and it does not say whether the recall was initiated voluntarily or ordered.

What Healthcare Providers Should Do

The only action listed in the notice is to contact the manufacturer if additional information is required. No refund, return or replacement process is described. The notice does not publish a phone number or email address for the manufacturer.

  • Check whether your facility operates a Magnetom Free.Max with model number 11408424 or 11408425.
  • Compare the lot or serial number on your system with 206217.
  • Contact Siemens Shenzhen Magnetic Resonance Ltd. or your local Siemens service representative for details on the NX VA60A-SP04 service pack.
  • Keep a record of any contact with the manufacturer and any service work carried out on the system.

Anyone who has a health or safety concern linked to a product can report it through the Government of Canada reporting page. People can also subscribe on the recalls site to receive email updates on new and updated recall notices.

Regulatory Response

Health Canada published the recall on its Recalls and Safety Alerts website as a Health product recall under identification number RA-82867. The original published date and the date modified are both October 27, 2026, while the recall date is recorded as October 20, 2026. The page states that the audience is healthcare and that the recommended step is to contact the manufacturer for more information.

Readers who want the full official wording can consult the Health Canada notice directly. Because the notice may be updated, facilities should also confirm with Siemens that they hold the most current information about the service pack and the affected lot.

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