Health Canada Type II Recall Hits Philips Azurion 7 Imaging Systems 2026

Health Canada has classified a recall of Philips Azurion 7 systems as Type II, after the manufacturer found that solid-state drives not specified in the medical device file may have been installed during certain repair or service actions. The recall was logged under identification number RA-82841, carries a recall date of October 8, 2026, and was published on the Health Canada recalls site on October 21, 2026.

The affected devices are radiology systems made by Philips Medical Systems Nederland B.V. of Best, Netherlands. The notice is aimed at healthcare audiences, not at general consumers.

Regulatory Response

The alert was published by Health Canada under its medical devices program and is filed as a health product recall in the radiology category. The recall is classed as Type II, and the stated issue is a medical device performance problem. The audience is listed as healthcare.

The notice does not describe a corrective action in detail. Its only instruction is that readers should contact the manufacturer if they require additional information.

Products Affected by This Recall

The recall covers specific Azurion 7 units identified by serial number and model or catalogue number. The notice lists 22 entries across three configurations.

• Azurion 7 B12 (catalogue number 722 067): serial numbers 128 and 151
• Azurion 7 M12 (catalogue number 722 223): serial number 119
• Azurion 7 M12 (catalogue number 722 078): serial numbers 205, 444, 218, 206 and 204
• Azurion 7 M20 (catalogue number 722 224): serial numbers 3459, 874, 2667, 495, 1156, 3596 and 875
• Azurion 7 M20 (catalogue number 722 079): serial numbers 284, 333, 1374, 783, 750, 679 and 352

Facilities should compare the serial and catalogue numbers on their equipment against this list, since only the listed units are named in the notice.

What Went Wrong?

Philips Azurion systems use solid-state drives, known as SSDs, inside various PCs. These drives store the operating system and image data and support system functionality.

According to the notice, Philips identified that during certain repair or service actions, SSDs that are not specified in the medical device file may have been installed. Such drives may have different performance characteristics, which may include reduced reliability over time.

In other words, the concern is not that every drive in the field is faulty. The concern is that a replacement drive outside the approved specification could have been fitted during servicing, and it may not hold up as intended.

Potential Impact on Imaging Operations

The symptoms depend on which PC contains the drive and which function is being used when the drive fails to perform as intended. The notice says this may result in the following problems.

• Loss of imaging functionality or motorized movement
• A blank or black display
• Inability to store newly acquired images
• Inability to access previously acquired images

For a radiology suite, any of these would interrupt use of the system. Loss of access to stored images may also affect the availability of patient imaging records held on the affected system.

Who Should Be Concerned

The alert is directed at healthcare audiences, which means hospitals, clinics and other facilities that operate Azurion 7 systems in Canada. Biomedical engineering and radiology department staff are the most likely to need the serial numbers and model details above.

Members of the public are not asked to take any action. Patients who have questions about imaging equipment at a specific facility should raise them with that facility.

Steps Facilities Should Take

The notice gives a single instruction: contact the manufacturer if you require additional information. It does not publish a phone number, email address or remediation schedule, so facilities should use their existing Philips service channels.

• Check each Azurion 7 system against the serial and catalogue numbers listed in the recall.
• Review service records for any repair or service actions that involved replacing drives.
• Contact Philips for further information about the recall and the affected units.

Quick Facts

• Recall number: RA-82841
• Recall class: Type II
• Recall date: 2026-10-08
• Published: 2026-10-21
• Manufacturer: Philips Medical Systems Nederland B.V.
• Issue: Medical devices – Performance

From the Agency

Health Canada states that Philips Azurion systems use SSDs in various PCs to store the operating system and image data, and that Philips has identified possible installation of SSDs not specified in the medical device file during certain repair or service actions. The agency adds that these drives may show reduced reliability over time.

Healthcare providers can subscribe to email updates on new and updated recalls and safety alerts through the Health Canada recalls website. Anyone with a health or safety concern related to a product can also report it through the department’s reporting page.